SEAT PLATE EXTENSION, SFC-PAD, EU
Report
- Report Number
- 3013876692-2024-00006
- Event Type
- Injury
- Date Received
- January 25, 2024
- Date of Event
- January 17, 2024
- Report Date
- June 18, 2024
- Manufacturer
- MAQUET GMBH
- Product Code
- BWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 17TH JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, PRESSURE INJURY ON THE LOWER BACK AND BUTTOCKS OF THE PATIENT WAS FOUND FOLLOWING THE PROCEDURE. THE PROVIDED INFORMATION SUGGESTS THAT THE PATIENT WAS POSITIONED PARTIALLY OVER THE EDGE OF THE OPERATING TABLE AND THE STAFF DID NOT USE THE RECOMMENDED SEAT PLATE EXTENSION. INITIALLY, IT WAS CONFIRMED THERE WERE NO OPEN WOUNDS AND NO MEDICAL INTERVENTION WAS NECESSARY. ON 24TH JANUARY 2024, ADDITIONAL DETAILS REGARDING SURGERY AND PATIENT'S INJURY WERE RECEIVED. AS IT WAS STATED, THE PATIENT'S SKIN WAS INTACT BEFORE SURGERY (GENITAL REASSIGNMENT MTF) AND THE INJURY WAS DISCOVERED DURING REPOSITIONING OF THE PATIENT. ACCORDING TO PROVIDED INFORMATION, THE PATIENT'S INJURY WAS ASSESSED AS DECUBITUS ULCER GRADE 2. THE PATIENT IS EXPERIENCING PAIN, SPECIAL POSITIONING IN BED IS REQUIRED AND THERE IS RESTRICTION OF MOBILITY. ADDITIONALLY, HYDROCOLLOID DRESSINGS ARE BEING APPLIED ON THE WOUND. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 17TH JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 116055BC - SEAT PLATE EXTENSION, SFC-PAD, EU USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, PRESSURE INJURY ON THE LOWER BACK AND BUTTOCKS OF THE PATIENT WAS FOUND FOLLOWING THE PROCEDURE. THE PROVIDED INFORMATION SUGGESTS THAT THE PATIENT WAS POSITIONED PARTIALLY OVER THE EDGE OF THE OPERATING TABLE AND THE STAFF DID NOT USE THE RECOMMENDED SEAT PLATE EXTENSION. INITIALLY, IT WAS CONFIRMED THERE WERE NO OPEN WOUNDS AND NO MEDICAL INTERVENTION WAS NECESSARY. ON 24TH JANUARY 2024, ADDITIONAL DETAILS REGARDING SURGERY AND PATIENT'S INJURY WERE RECEIVED. AS IT WAS STATED, THE PATIENT'S SKIN WAS INTACT BEFORE SURGERY (GENITAL REASSIGNMENT MTF) AND THE INJURY WAS DISCOVERED DURING REPOSITIONING OF THE PATIENT. ACCORDING TO PROVIDED INFORMATION, THE PATIENT'S INJURY WAS ASSESSED AS DECUBITUS ULCER GRADE 2. THE PATIENT IS EXPERIENCING PAIN, SPECIAL POSITIONING IN BED IS REQUIRED AND THERE IS RESTRICTION OF MOBILITY. ADDITIONALLY, HYDROCOLLOID DRESSINGS ARE BEING APPLIED ON THE WOUND. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY. PREVIOUS D1 BRAND NAME: MEERA EU WITH AUTO DRIVE, CORRECTED D1 BRAND NAME: SEAT PLATE EXTENSION, SFC-PAD, EU. PREVIOUS D2 COMMON DEVICE NAME: FQO TABLE, OPERATING-ROOM, AC-POWERED, CORRECTED D2 COMMON DEVICE NAME: BWN TABLE AND ATTACHMENTS, OPERATING-ROOM. PREVIOUS D4 VERSION OR MODEL #: 720001B2, CORRECTED D4 VERSION OR MODEL #: 116055BC. PREVIOUS D4 CATALOG #: 720001B2, CORRECTED D4 CATALOG #: 116055BC.
ON (B)(6) 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 116055BC - SEAT PLATE EXTENSION, SFC-PAD, EU USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, PRESSURE INJURY ON THE LOWER BACK AND BUTTOCKS OF THE PATIENT WAS FOUND FOLLOWING THE PROCEDURE. THE PROVIDED INFORMATION SUGGESTS THAT THE PATIENT WAS POSITIONED PARTIALLY OVER THE EDGE OF THE OPERATING TABLE AND THE STAFF DID NOT USE THE RECOMMENDED SEAT PLATE EXTENSION. INITIALLY, IT WAS CONFIRMED THERE WERE NO OPEN WOUNDS AND NO MEDICAL INTERVENTION WAS NECESSARY. ON (B)(6) 2024, ADDITIONAL DETAILS REGARDING SURGERY AND THE PATIENT'S INJURY WERE RECEIVED. AS IT WAS STATED, THE PATIENT'S SKIN WAS INTACT BEFORE SURGERY (GENITAL REASSIGNMENT MTF) AND THE INJURY WAS DISCOVERED DURING REPOSITIONING OF THE PATIENT. ACCORDING TO THE PROVIDED INFORMATION, THE PATIENT'S INJURY WAS ASSESSED AS DECUBITUS ULCER GRADE 2. THE PATIENT IS EXPERIENCING PAIN, SPECIAL POSITIONING IN BED IS REQUIRED AND THERE IS RESTRICTION OF MOBILITY. ADDITIONALLY, HYDROCOLLOID DRESSINGS ARE BEING APPLIED TO THE WOUND. NO MORE INFORMATION ABOUT THE PATIENT'S STATE OF HEALTH WAS PROVIDED. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS IT WAS CONFIRMED THAT THE ISSUE WAS CAUSED BY INAPPROPRIATE PATIENT POSITIONING, IT WAS CONSIDERED THAT THE GETINGE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE SERIOUS INJURIES OF THE PATIENT WHEN THIS PARTICULAR SITUATION OCCURRED. COMPARING THE NUMBER OF DEVICES INVOLVED IN THE ADVERSE EVENT TO THE NUMBER OF 116055 SEAT PLATE EXTENSION ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS (B)(4) FOR THE ISSUE INVESTIGATED HEREIN. REGARDING THE CONFIGURATION OF BOTH DEVICES, COMPARING THE NUMBER OF DEVICES INVOLVED IN THE ADVERSE EVENT TO THE NUMBER OF 116055 SEAT PLATE EXTENSION AND MEERA MOBILE TABLES ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS (B)(4) FOR THE ISSUE INVESTIGATED HEREIN. THE GETINGE TECHNICIAN VISITED THE CUSTOMER TO PERFORM THE ROOT CAUSE EVALUATION. IT WAS ASSESSED THAT THE POSITIONING OF THE PATIENT WAS NOT PERFORMED CORRECTLY. ACCORDING TO THE TECHNICIAN, THE PATIENT WAS POSITIONED OVER THE EDGE OF THE OPERATING TABLE AND LAY WITH HIS BUTTOCKS PARTIALLY EXPOSED ON THE EDGE AND IN THE AIR. IN THE USER MANUAL (IFU 1160.55 REV. 08, PAGE 12), THE USER IS INFORMED ABOUT THE RISK POSED TO THE PATIENT'S VITAL FUNCTIONS DUE TO INCORRECT POSITIONING. THE USER IS INSTRUCTED TO POSITION THE PATIENT CORRECTLY AND KEEP UNDER PERMANENT OBSERVATION. MOREOVER, THE USER IS ALSO INFORMED THAT IMPROPER PATIENT POSITIONING MAY CAUSE HEALTH DAMAGE (E. G. DECUBITUS). THE ISSUE INVESTIGATED HEREIN WAS ALSO CONSULTED WITH A MEDICAL EXPERT. IT WAS CONFIRMED THAT THE PATIENT'S INJURY RESULTED FROM A USER ERROR. THE TECHNICIAN CONFIRMED THAT THE CUSTOMER WAS INFORMED THAT IT IS NOT PERMITTED TO POSITION THE PATIENT PARTIALLY OVER THE OPERATING TABLE. IN SUMMARY AND AS A RESULT OF THE ROOT CAUSE EVALUATION, IT CAN BE CONCLUDED THAT THE MOST POSSIBLE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE PATIENT SUFFERING THE DECUBITUS ULCER GRADE 2 CONSTITUTING A SERIOUS INJURY, IS USER ERROR. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE CORRECTION OF B1 ADVERSE EVENT / PRODUCT PROBLEM, B5 DESCRIBE EVENT OR PROBLEM, H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT & PRODUCT PROBLEM CORRECTED B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 116055BC - SEAT PLATE EXTENSION, SFC-PAD, EU USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, PRESSURE INJURY ON THE LOWER BACK AND BUTTOCKS OF THE PATIENT WAS FOUND FOLLOWING THE PROCEDURE. THE PROVIDED INFORMATION SUGGESTS THAT THE PATIENT WAS POSITIONED PARTIALLY OVER THE EDGE OF THE OPERATING TABLE AND THE STAFF DID NOT USE THE RECOMMENDED SEAT PLATE EXTENSION. INITIALLY, IT WAS CONFIRMED THERE WERE NO OPEN WOUNDS AND NO MEDICAL INTERVENTION WAS NECESSARY. ON (B)(6) 2024, ADDITIONAL DETAILS REGARDING SURGERY AND PATIENT'S INJURY WERE RECEIVED. AS IT WAS STATED, THE PATIENT'S SKIN WAS INTACT BEFORE SURGERY (GENITAL REASSIGNMENT MTF) AND THE INJURY WAS DISCOVERED DURING REPOSITIONING OF THE PATIENT. ACCORDING TO PROVIDED INFORMATION, THE PATIENT'S INJURY WAS ASSESSED AS DECUBITUS ULCER GRADE 2. THE PATIENT IS EXPERIENCING PAIN, SPECIAL POSITIONING IN BED IS REQUIRED AND THERE IS RESTRICTION OF MOBILITY. ADDITIONALLY, HYDROCOLLOID DRESSINGS ARE BEING APPLIED ON THE WOUND. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON (B)(6) 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 116055BC - SEAT PLATE EXTENSION, SFC-PAD, EU USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, PRESSURE INJURY ON THE LOWER BACK AND BUTTOCKS OF THE PATIENT WAS FOUND FOLLOWING THE PROCEDURE. THE PROVIDED INFORMATION SUGGESTS THAT THE PATIENT WAS POSITIONED PARTIALLY OVER THE EDGE OF THE OPERATING TABLE AND THE STAFF DID NOT USE THE RECOMMENDED SEAT PLATE EXTENSION. INITIALLY, IT WAS CONFIRMED THERE WERE NO OPEN WOUNDS AND NO MEDICAL INTERVENTION WAS NECESSARY. ON (B)(6) 2024, ADDITIONAL DETAILS REGARDING SURGERY AND THE PATIENT'S INJURY WERE RECEIVED. AS IT WAS STATED, THE PATIENT'S SKIN WAS INTACT BEFORE SURGERY (GENITAL REASSIGNMENT MTF) AND THE INJURY WAS DISCOVERED DURING REPOSITIONING OF THE PATIENT. ACCORDING TO THE PROVIDED INFORMATION, THE PATIENT'S INJURY WAS ASSESSED AS DECUBITUS ULCER GRADE 2. THE PATIENT IS EXPERIENCING PAIN, SPECIAL POSITIONING IN BED IS REQUIRED AND THERE IS RESTRICTION OF MOBILITY. ADDITIONALLY, HYDROCOLLOID DRESSINGS ARE BEING APPLIED TO THE WOUND. NO MORE INFORMATION ABOUT THE PATIENT'S STATE OF HEALTH WAS PROVIDED. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A.
H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER
ON 17TH JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 116055BC - SEAT PLATE EXTENSION, SFC-PAD, EU USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, PRESSURE INJURY ON THE LOWER BACK AND BUTTOCKS OF THE PATIENT WAS FOUND FOLLOWING THE PROCEDURE. THE PROVIDED INFORMATION SUGGESTS THAT THE PATIENT WAS POSITIONED PARTIALLY OVER THE EDGE OF THE OPERATING TABLE AND THE STAFF DID NOT USE THE RECOMMENDED SEAT PLATE EXTENSION. INITIALLY, IT WAS CONFIRMED THERE WERE NO OPEN WOUNDS AND NO MEDICAL INTERVENTION WAS NECESSARY. ON 24TH JANUARY 2024, ADDITIONAL DETAILS REGARDING SURGERY AND PATIENT'S INJURY WERE RECEIVED. AS IT WAS STATED, THE PATIENT'S SKIN WAS INTACT BEFORE SURGERY (GENITAL REASSIGNMENT MTF) AND THE INJURY WAS DISCOVERED DURING REPOSITIONING OF THE PATIENT. ACCORDING TO PROVIDED INFORMATION, THE PATIENT'S INJURY WAS ASSESSED AS DECUBITUS ULCER GRADE 2. THE PATIENT IS EXPERIENCING PAIN, SPECIAL POSITIONING IN BED IS REQUIRED AND THERE IS RESTRICTION OF MOBILITY. ADDITIONALLY, HYDROCOLLOID DRESSINGS ARE BEING APPLIED ON THE WOUND. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY.
ON (B)(6) 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 116055BC - SEAT PLATE EXTENSION, SFC-PAD, EU USED WITH 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, PRESSURE INJURY ON THE LOWER BACK AND BUTTOCKS OF THE PATIENT WAS FOUND FOLLOWING THE PROCEDURE. THE PROVIDED INFORMATION SUGGESTS THAT THE PATIENT WAS POSITIONED PARTIALLY OVER THE EDGE OF THE OPERATING TABLE AND THE STAFF DID NOT USE THE RECOMMENDED SEAT PLATE EXTENSION. INITIALLY, IT WAS CONFIRMED THERE WERE NO OPEN WOUNDS AND NO MEDICAL INTERVENTION WAS NECESSARY. ON (B)(6) 2024, ADDITIONAL DETAILS REGARDING SURGERY AND THE PATIENT'S INJURY WERE RECEIVED. AS IT WAS STATED, THE PATIENT'S SKIN WAS INTACT BEFORE SURGERY (GENITAL REASSIGNMENT MTF) AND THE INJURY WAS DISCOVERED DURING REPOSITIONING OF THE PATIENT. ACCORDING TO THE PROVIDED INFORMATION, THE PATIENT'S INJURY WAS ASSESSED AS DECUBITUS ULCER GRADE 2. THE PATIENT IS EXPERIENCING PAIN, SPECIAL POSITIONING IN BED IS REQUIRED AND THERE IS RESTRICTION OF MOBILITY. ADDITIONALLY, HYDROCOLLOID DRESSINGS ARE BEING APPLIED TO THE WOUND. NO MORE INFORMATION ABOUT THE PATIENT'S STATE OF HEALTH WAS PROVIDED. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY.
ON 17TH JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 720001B2 - MEERA EU WITH AUTO DRIVE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, PRESSURE INJURY ON THE LOWER BACK AND BUTTOCKS OF THE PATIENT WAS FOUND FOLLOWING THE PROCEDURE. THE PROVIDED INFORMATION SUGGESTS THAT THE PATIENT WAS POSITIONED PARTIALLY OVER THE EDGE OF THE OPERATING TABLE AND THE STAFF DID NOT USE THE RECOMMENDED SEAT PLATE EXTENSION. INITIALLY, IT WAS CONFIRMED THERE WERE NO OPEN WOUNDS AND NO MEDICAL INTERVENTION WAS NECESSARY. ON 24TH JANUARY 2024, ADDITIONAL DETAILS REGARDING SURGERY AND PATIENT'S INJURY WERE RECEIVED. AS IT WAS STATED, THE PATIENT'S SKIN WAS INTACT BEFORE SURGERY (GENITAL REASSIGNMENT MTF) AND THE INJURY WAS DISCOVERED DURING REPOSITIONING OF THE PATIENT. ACCORDING TO PROVIDED INFORMATION, THE PATIENT'S INJURY WAS ASSESSED AS DECUBITUS ULCER GRADE 2. THE PATIENT IS EXPERIENCING PAIN, SPECIAL POSITIONING IN BED IS REQUIRED AND THERE IS RESTRICTION OF MOBILITY. ADDITIONALLY, HYDROCOLLOID DRESSINGS ARE BEING APPLIED ON THE WOUND. WE DECIDED TO REPORT THE ISSUE DUE TO THE DESCRIBED OUTCOME OF THE EVENT, WHICH CONSTITUTES A SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1972882 | SEAT PLATE EXTENSION, SFC-PAD, EU | TABLE AND ATTACHMENTS, OPERATING-ROOM | BWN | MAQUET GMBH | 116055BC | ||
| 64776 | SEAT PLATE EXTENSION, SFC-PAD, EU | TABLE AND ATTACHMENTS, OPERATING-ROOM | BWN | MAQUET GMBH | 116055BC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | 720001B2 MEERA EU WITH AUTO DRIVE |