1093 OTOSCAN
Report
- Report Number
- 9612197-2022-00008
- Event Type
- Malfunction
- Date Received
- October 20, 2022
- Date of Event
- October 17, 2022
- Report Date
- March 16, 2023
- Manufacturer
- NATUS MEDICAL DENMARK APS
- Product Code
- ERA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4). CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE FOR EVALUATION. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE) COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOC- 060538 NO TREND FOR THIS FAILURE IDENTIFIED THE CURRENT RISK FILE DOC-036156 REV 05 1093 OTOSCAN - RISK ANALYSIS SPREADSHEET HAZARD ID 6.5 IDENTIFIES THIS ISSUE HARM - USER & PATIENT INJURY CAUSE- DEVICE HAS ROUGH, SURFACE AND/OR SHARP CORNERS &/OR EDGES SEVERITY- MARGINAL (3) RISK LEVEL- MINOR (9). A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. CERTIFICATE OF COMPLIANCE WAS REVIEWED, AND NO RELATED FAULTS/ISSUE FOUND.
FOLLOW UP REPORT 003 REF NATUS COMPLAINT#(B)(4). INSTALL DATE OF DEVICE: (B)(6) 2021. THE CUSTOMER RETURNED THE DEVICE FOR EVALUATION. THE FOLLOWING INVESTIGATION RESULTS WERE MADE AVAILABLE: THE GLASS PART OF THE SCANNER WAS EXAMINED, BUT NO DAMAGE OR SHARP EDGES WERE DISCOVERED. THE METAL PARTS WERE ALSO LOOKED AT AND DISCOVERED NO DAMAGE OR SHARP EDGES. HOWEVER, THERE WERE MINOR SCRATCHES IN THE AXIAL DIRECTION, WHICH CAN HAPPEN IF THE DEVICE WAS HANDLED INCORRECTLY. ROOT CAUSE/PROBABLE ROOT CAUSE: THE SCANNER TIP WAS NOT DAMAGED, AND THERE WERE NO SHARP EDGES. THE EQUIPMENT WAS THOROUGHLY INVESTIGATED, AND NO PROBLEMS WERE NOTED. FAILURE CONFIRMED: NO. INVESTIGATION RESULT CODE: TAASTRUP/NO FAULT FOUND. CLOSURE RATIONALE:COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE.
FOLLOW UP REPORT 002 REF NATUS COMPLAINT (B)(4). CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE FOR EVALUATION. JAN 13, 2023 - WAITING FOR THE DEVICE TO BE RETURNED. A REPLACEMENT DEVICE TO BE SHIPPED TO THE CUSTOMER.
INITIAL REPORT REF NATUS COMPLAINT# (B)(4). DEVICE WILL BE REQUESTED FOR RETURN AND EXAMINATION. INSTALL DATE OF THE DEVICE WAS (B)(6) 2021.
THE COMPLAINANT SAID THAT THE 1096 OTOSCAN IN HER POSSESSION MAY HAVE, THROUGH THE SHARP CORNER AT THE END OF THE PROBE, SCARRED A FEMALE PATIENT WHO SUFFERED LATER ON SOME EAR BLEEDING.
THE COMPLAINANT SAID THAT THE 1096 OTOSCAN IN HER POSSESSION MAY HAVE, THROUGH THE SHARP CORNER AT THE END OF THE PROBE, SCARRED A FEMALE PATIENT WHO SUFFERED LATER ON SOME EAR BLEEDING.
THE COMPLAINANT SAID THAT THE 1096 OTOSCAN IN HER POSSESSION MAY HAVE, THROUGH THE SHARP CORNER AT THE END OF THE PROBE, SCARRED A FEMALE PATIENT WHO SUFFERED LATER ON SOME EAR BLEEDING.
THE COMPLAINANT SAID THAT THE 1096 OTOSCAN IN HER POSSESSION MAY HAVE, THROUGH THE SHARP CORNER AT THE END OF THE PROBE, SCARRED A FEMALE PATIENT WHO SUFFERED LATER ON SOME EAR BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2562013 | 1093 OTOSCAN | 1093 OTOSCAN | ERA | NATUS MEDICAL DENMARK APS | 8-04-15400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female |