MEERA
Report
- Report Number
- 8010652-2023-00119
- Event Type
- Malfunction
- Date Received
- November 10, 2023
- Report Date
- November 10, 2023
- Manufacturer
- MAQUET GMBH
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1H EVENT SITE POSTAL CODE: (B)(6).H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 720001B0 - MEERA EU WITHOUT AUTO DRIVE. AS IT WAS STATED, THE USER GOT AN ELECTRIC SHOCK FROM THE TABLE. IT WAS CONFIRMED NO BARE CONTACTS, POLES OR ELECTRICAL PARTS WERE VISIBLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE ELECTRIC SHOCK OF THE USER, WAS TO REOCCUR. RECENTLY, NEW INFORMATION WAS PROVIDED BY THE GETINGE TECHNICIAN. THE TECHNICIAN STATED THAT THE ISSUE OCCURRED DURING A ROUTINE CHECKUP. THE CUSTOMER WAS STANDING ON THE SMALL TABLE WHICH WAS MADE OF METAL. THAT TABLE WAS TOUCHING THE MEERA OPERATING TABLE. THE CUSTOMER COMPLAINED THAT WHENEVER THEY STOOD ON THE SMALL METAL TABLE, THEY GOT A LITTLE ELECTRIC PINCH FROM THE MEERA TABLE¿S SIDE RAIL. THE AFFECTED GETINGE DEVICE HAS BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN. THE TECHNICIAN COULD NOT DUPLICATE THE REPORTED ISSUE AND COULD NOT FIND ANY PROBLEM WITH OUR OPERATING TABLE. THE EVENT REPORTED IN THIS COMPLAINT WAS REEVALUATED BY THE CLINICAL EXPERT AND SUBJECT MATTER EXPERT FROM THE MANUFACTURING SITE AND ASSESSED AS A NON-SAFETY NOR RISK-RELATED ISSUE. THEREFORE, THE INITIALLY CONSIDERED POTENTIAL RISK FOR THE USER RESULTING FROM THE ELECTRIC SHOCK CAN BE EXCLUDED. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS NOT BEING USED FOR THE PATIENT¿S TREATMENT AND WAS ALSO NOT DIRECTLY INVOLVED WITH ANY ADVERSE EVENT. AS NO MALFUNCTIONS WERE FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER NOR A PATIENT OR OPERATOR WHEN THIS PARTICULAR EVENT OCCURRED. THE ISSUE IS A SINGLE AND ISOLATED CASE. ACCORDING TO THE SUBJECT MATTER EXPERTS (SMES) AT THE MANUFACTURING SITE, AS NO FAULT COULD BE DETECTED IN THE OPERATING TABLE, THE SMES COULD NOT FIND A SCENARIO IN WHICH OUR OPERATING TABLE COULD GIVE AN ELECTRIC SHOCK. IT HAS BEEN ESTABLISHED THAT THE ELECTRIC SHOCK WAS CAUSED BY ESD. IF THE METAL TABLE HAD HAD PLASTIC FEET OR THE CUSTOMER HAD BEEN WEARING INSULATING PLASTIC SHOES, IT IS POSSIBLE THAT THE CUSTOMER HAS BECOME STATICALLY CHARGED. IF THE CUSTOMER THEN TOUCHED THE OPERATING TABLE, THE ELECTROSTATIC CHARGE DISCHARGED VIA THE OPERATING TABLE, WHICH WAS PROBABLY ALSO CONNECTED TO THE POTENTIAL EQUALIZATION. AS THE ELECTRIC SHOCK DID NOT ORIGINATE FROM OUR OPERATING TABLE IT IS IMPOSSIBLE TO ASSESS THE RECEIVED VOLTAGE RANGE. EVERY USER IS INFORMED IN THE INSTRUCTION FOR USE (IFU 7200.01 EN 12, PAGE 64), THAT WITHOUT EQUIPOTENTIAL BONDING, PRODUCTS WITH DIFFERING ELECTRICAL POTENTIALS MAY CAUSE SHORT CIRCUITS ON THE OPERATING TABLE. THE USER SHALL ESTABLISH POTENTIAL BONDING PRIOR TO EACH USE OF THE OPERATING TABLE. THE USER IS ALSO WARNED THAT IF UNSUITABLE CLEANING AGENTS AND DISINFECTANTS ARE USED, THE ANTISTATIC PROPERTY AND ELECTRICAL CONDUCTIVITY OF THE PRODUCT MAY BE LOST, WHICH ARE REQUIRED TO PREVENT ELECTROSTATIC CHARGES AS REQUIRED BY THE STANDARD. THE OPERATING TABLE HAS BEEN THOROUGHLY TESTED FOR ELECTROMAGNETIC EMISSIONS ACCORDING TO STANDARDS: IEC 60601-1-2, EC 61000-3-2, IEC 61000-3-3 AND CISPR 11; AND FOR RESISTANCE TO ELECTROMAGNETIC INTERFERENCE ACCORDING TO STANDARDS: IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8 AND IEC 61000-4-11. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT NO MALFUNCTIONS COULD BE DETECTED ON SITE AND THE SME COULD NOT ESTABLISH A SCENARIO IN WHICH OUR OPERATING TABLE COULD CONTRIBUTE TO THE ISSUE OCCURRENCE. 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 B5 DESCRIBE EVENT OR PROBLEM, H4 DEVICE MANUFACTURE DATE, H6 HEALTH EFFECT ¿ CLINICAL CODE, H6 MEDICAL DEVICE ¿ PROBLEM CODE AND H6 HEALTH EFFECT ¿ IMPACT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AND ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 31ST OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 720001B0 - MEERA EU WITHOUT AUTO DRIVE. AS IT WAS STATED, USER GOT ELECTRIC SHOCK FROM TABLE. IT WAS CONFIRMED NO BARE CONTACTS, POLES OR ELECTRICAL PARTS WERE VISIBLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, TO DATE NO MORE DETAILS OF THE INCIDENT HAVE BEEN RECEIVED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY ELECTRIC SHOCK OF THE USER, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 31ST OCTOBER 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 720001B0 - MEERA EU WITHOUT AUTO DRIVE. AS IT WAS STATED, THE USER GOT AN ELECTRIC SHOCK FROM THE TABLE. IT WAS CONFIRMED NO BARE CONTACTS, POLES OR ELECTRICAL PARTS WERE VISIBLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE ELECTRIC SHOCK OF THE USER, WAS TO REOCCUR. RECENTLY, NEW INFORMATION WAS PROVIDED BY THE GETINGE TECHNICIAN. THE TECHNICIAN STATED THAT THE ISSUE OCCURRED DURING A ROUTINE CHECKUP. THE CUSTOMER WAS STANDING ON THE SMALL TABLE WHICH WAS MADE OF METAL. THAT TABLE WAS TOUCHING THE MEERA OPERATING TABLE. THE CUSTOMER COMPLAINED THAT WHENEVER THEY STOOD ON THE SMALL METAL TABLE, THEY GOT A LITTLE ELECTRIC PINCH FROM THE MEERA TABLE¿S SIDE RAIL. THE AFFECTED GETINGE DEVICE HAS BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN THE TECHNICIAN COULD NOT DUPLICATE THE REPORTED ISSUE AND COULD NOT FIND ANY PROBLEM WITH OUR OPERATING TABLE. THE EVENT REPORTED IN THIS COMPLAINT WAS REEVALUATED BY THE CLINICAL EXPERT AND SUBJECT MATTER EXPERT FROM THE MANUFACTURING SITE AND ASSESSED AS A NON-SAFETY NOR RISK-RELATED ISSUE. THEREFORE, THE INITIALLY CONSIDERED POTENTIAL RISK FOR THE USER RESULTING FROM THE ELECTRIC SHOCK CAN BE EXCLUDED. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. PREVIOUS H4 DEVICE MANUFACTURE DATE: (B)(6) 2022 CORRECTED H4 DEVICE MANUFACTURE DATE: (B)(6) 2022 PREVIOUS H6 HEALTH EFFECT ¿ CLINICAL CODE: OTHERS/INSUFFICIENT INFORMATION//4580 CORRECTED H6 HEALTH EFFECT ¿ CLINICAL CODE: OTHERS/NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS//4582 PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: ELECTRICAL /ELECTRONIC PROPERTY PROBLEM/UNINTENDED ELECTRICAL SHOCK//4018 CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: ELECTRICAL /ELECTRONIC PROPERTY PROBLEM/ELECTRO-STATIC DISCHARGE//2149 NO APPARENT ADVERSE EVENT///3189 PREVIOUS H6 HEALTH EFFECT ¿ IMPACT CODES: INSUFFICIENT INFORMATION///4648 CORRECTED H6 HEALTH EFFECT ¿ IMPACT CODES: NO HEALTH CONSEQUENCES OR IMPACT///2199.
ON 31ST OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 720001B0 - MEERA EU WITHOUT AUTO DRIVE. AS IT WAS STATED, USER GOT ELECTRIC SHOCK FROM TABLE. IT WAS CONFIRMED NO BARE CONTACTS, POLES OR ELECTRICAL PARTS WERE VISIBLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, TO DATE NO MORE DETAILS OF THE INCIDENT HAVE BEEN RECEIVED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY ELECTRIC SHOCK OF THE USER, WAS TO REOCCUR.
ON 31ST OCTOBER 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 720001B0 - MEERA EU WITHOUT AUTO DRIVE. AS IT WAS STATED, THE USER GOT AN ELECTRIC SHOCK FROM THE TABLE. IT WAS CONFIRMED NO BARE CONTACTS, POLES OR ELECTRICAL PARTS WERE VISIBLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE ELECTRIC SHOCK OF THE USER, WAS TO REOCCUR. RECENTLY, NEW INFORMATION WAS PROVIDED BY THE GETINGE TECHNICIAN. THE TECHNICIAN STATED THAT THE ISSUE OCCURRED DURING A ROUTINE CHECKUP. THE CUSTOMER WAS STANDING ON THE SMALL TABLE WHICH WAS MADE OF METAL. THAT TABLE WAS TOUCHING THE MEERA OPERATING TABLE. THE CUSTOMER COMPLAINED THAT WHENEVER THEY STOOD ON THE SMALL METAL TABLE, THEY GOT A LITTLE ELECTRIC PINCH FROM THE MEERA TABLE¿S SIDE RAIL. THE AFFECTED GETINGE DEVICE HAS BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN THE TECHNICIAN COULD NOT DUPLICATE THE REPORTED ISSUE AND COULD NOT FIND ANY PROBLEM WITH OUR OPERATING TABLE. THE EVENT REPORTED IN THIS COMPLAINT WAS REEVALUATED BY THE CLINICAL EXPERT AND SUBJECT MATTER EXPERT FROM THE MANUFACTURING SITE AND ASSESSED AS A NON-SAFETY NOR RISK-RELATED ISSUE. THEREFORE, THE INITIALLY CONSIDERED POTENTIAL RISK FOR THE USER RESULTING FROM THE ELECTRIC SHOCK CAN BE EXCLUDED. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103809 | MEERA | TABLE, OPERATING-ROOM, AC-POWERED | FQO | MAQUET GMBH | 720001B0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |