KE398-DW,KEY 3,GN RESOUND
Report
- Report Number
- 3005650109-2022-00009
- Event Type
- Malfunction
- Date Received
- July 1, 2022
- Report Date
- July 25, 2022
- Manufacturer
- GN HEARING A/S
- Product Code
- OSM
- UDI-DI
- 05708296209736
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
HOLD FOR MB 11.2318OCT2021: INITIAL FDA REPORTING RATIONAL. THE CURRENT INFORMATION INDICATES NO NEED FOR IMMEDIATE REPORTING AS THERE IS NO PUBLIC HEALTH THREAT.RISK REGISTER REFERENCE: 0394140RC RISK-REGIST APOLLO 5.2_5.3 RISK ID T.1-7A, S2.#0409290 HAS INVESTIGATED WORST-CASE TEMPERATURE INCREASE OF GN RECHARGEABLE HEARING AIDS IN SINGLE-FAULT CONDITION. CONCLUSION OF THE INVESTIGATION IS THAT REQUIREMENTS FROM IEC 60601-1:2006+A12:2014 ARE MET. THE CLINICAL CONCLUSION WAS THAT IT IS UNLIKELY THAT THE DEVICE IN SINGLE-FAULT CONDITION WOULD CAUSE HARM.ACCORDING TO 0394140 TEMPL MD-RISK REGIST HW RISK T.1-2A THE SEVERITY IS 2 WHICH IS CONSIDERED MARGINAL.HOWEVER, ON 29JUN2022, IT WAS REASSESSED AS REPORTABLE. BASED ON THE DEVICE MALFUNCTION AND THAT A MALFUNCTION BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.THE EVENT DESCRIBED - HEARING AID IS MELTED - BURNED BADLY' . IT HAS BEEN CONFIRMED THAT NO PATIENT HAS BEEN HARMED.30JUN2022: CLINICAL EVALUATION:A NON-RECHARGEABLE HEARING AID WITH DISPOSABLE ZINC-AIR BATTERIES WAS PLACED INTO AN UNKNOWN CHARGER, CAUSING IT TO MELT AND BURN. IT IS UNCLEAR HOW THE END USER CAME TO BE IN POSSESSION OF A CHARGER OR WHAT MODEL CHARGER THEY USED. NO HARM WAS CAUSED TO THE END USER.THIS INCIDENT WAS A RESULT OF IMPROPER USE OF A HEARING INSTRUMENT BY AN END USER. 0378040 CLIN EVAL PLAN&RPT,HA&TSG STATES THAT "GN HEARING RECHARGEABLE HEARING AIDS SHOULD ONLY BE CHARGED ON THE SUPPLIED CHARGER"; WHILE THE DEVICE IN QUESTION IS NOT A RECHARGEABLE HEARING AID, IT WAS USED WITH A CHARGER THAT WAS NOT SUPPLIED WITH THE HEARING AID. 0378080 CLIN EVAL PLAN&RPT,WL ACC SECTION 9.1 LISTS THE FOLLOWING INTENDED PURPOSE FOR CHARGERS: "THE HEARING AID CHARGER IS INTENDED TO CHARGE RECHARGEABLE HEARING AIDS. THE CHARGER IS INTENDED TO BE USED ONLY WITH [BRAND AND /OR DEVICE NAME] RECHARGEABLE HEARING AIDS". ADDITIONALLY, THE HEARING INSTRUMENT USER GUIDE 401377000 UG,RS KEY,HP/SP BTE,GB LISTS UNDER "BATTERY WARNINGS", "DO NOT RECHARGE ZINC-AIR BATTERIES - THEY MAY LEAK OR EXPLODE". WHILE THIS THESE SECTIONS OF THE CER DESCRIBE ASPECTS OF THIS EVENT AND WHILE THE USER GUIDE INDICATES THAT THIS EVENT WAS NOT ENTIRELY UNFORESEEN, THERE IS NO SPECIFIC MENTION OF OR WARNINGS AGAINST PUTTING NON-RECHARGEABLE HEARING INSTRUMENTS IN A CHARGER IN THE CER. FOR THIS REASON, A CER UPDATE WILL BE CONSIDERED.A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE.THE DEVICE INVESTIGATIONS ARE PENDING AND THEY WILL BE PROVIDED ONCE READY.
18OCT2021: INITIAL FDA REPORTING RATIONAL. THE CURRENT INFORMATION INDICATES NO NEED FOR IMMEDIATE REPORTING AS THERE IS NO PUBLIC HEALTH THREAT. RISK REGISTER REFERENCE: 0394140RC RISK-REGIST APOLLO 5.2_5.3 RISK ID T.1-7A, S2. #0409290 HAS INVESTIGATED WORST-CASE TEMPERATURE INCREASE OF GN RECHARGEABLE HEARING AIDS IN SINGLE-FAULT CONDITION. CONCLUSION OF THE INVESTIGATION IS THAT REQUIREMENTS FROM IEC 60601-1:2006+A12:2014 ARE MET. THE CLINICAL CONCLUSION WAS THAT IT IS UNLIKELY THAT THE DEVICE IN SINGLE-FAULT CONDITION WOULD CAUSE HARM. ACCORDING TO 0394140 TEMPL MD-RISK REGIST HW RISK T.1-2A THE SEVERITY IS 2 WHICH IS CONSIDERED MARGINAL. HOWEVER, ON 29JUN2022, IT WAS REASSESSED AS REPORTABLE. BASED ON THE DEVICE MALFUNCTION AND THAT A MALFUNCTION BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THE EVENT DESCRIBED - HEARING AID IS MELTED - BURNED BADLY' . IT HAS BEEN CONFIRMED THAT NO PATIENT HAS BEEN HARMED. 30JUN2022: CLINICAL EVALUATION: A NON-RECHARGEABLE HEARING AID WITH DISPOSABLE ZINC-AIR BATTERIES WAS PLACED INTO AN UNKNOWN CHARGER, CAUSING IT TO MELT AND BURN. IT IS UNCLEAR HOW THE END USER CAME TO BE IN POSSESSION OF A CHARGER OR WHAT MODEL CHARGER THEY USED. NO HARM WAS CAUSED TO THE END USER. THIS INCIDENT WAS A RESULT OF IMPROPER USE OF A HEARING INSTRUMENT BY AN END USER. 0378040 CLIN EVAL PLAN&RPT,HA&TSG STATES THAT "GN HEARING RECHARGEABLE HEARING AIDS SHOULD ONLY BE CHARGED ON THE SUPPLIED CHARGER"; WHILE THE DEVICE IN QUESTION IS NOT A RECHARGEABLE HEARING AID, IT WAS USED WITH A CHARGER THAT WAS NOT SUPPLIED WITH THE HEARING AID. 0378080 CLIN EVAL PLAN&RPT,WL ACC SECTION 9.1 LISTS THE FOLLOWING INTENDED PURPOSE FOR CHARGERS: "THE HEARING AID CHARGER IS INTENDED TO CHARGE RECHARGEABLE HEARING AIDS. THE CHARGER IS INTENDED TO BE USED ONLY WITH [BRAND AND /OR DEVICE NAME] RECHARGEABLE HEARING AIDS". ADDITIONALLY, THE HEARING INSTRUMENT USER GUIDE 401377000 UG,RS KEY,HP/SP BTE,GB LISTS UNDER "BATTERY WARNINGS", "DO NOT RECHARGE ZINC-AIR BATTERIES - THEY MAY LEAK OR EXPLODE". WHILE THIS THESE SECTIONS OF THE CER DESCRIBE ASPECTS OF THIS EVENT AND WHILE THE USER GUIDE INDICATES THAT THIS EVENT WAS NOT ENTIRELY UNFORESEEN, THERE IS NO SPECIFIC MENTION OF OR WARNINGS AGAINST PUTTING NON-RECHARGEABLE HEARING INSTRUMENTS IN A CHARGER IN THE CER. FOR THIS REASON, A CER UPDATE WILL BE CONSIDERED. A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. 25JUL2022: DEVICE INVESTIGATION HAS BEEN CONCLUDED. THE SUSPECTED DEVICE WAS ANALYSED.- 'THE HEARING AID HAS VISIBLE SIGNS OF DAMAGE ON THE OUTER SHELL. THE UPPER PART OF THE OUTER SHELL HAS DISAPPEARED SHOWING THE HYBRID, WHICH IS COLOURED DARK BY THE HEAT. INSIDE THE BATTERY CHAMBER THE ZINC AIR BATTERY CAN BE SEEN. WHEN TRYING TO LOOK INSIDE THE BATTEY CHAMBER. IT APPEARS WITHOUT MAJOR VISIBLE DAMAGE. THE DEVICE SHOWED THAT IT WAS FILLED WITH SOOT. IT HAS BEEN OBVIOUS THAT THE INSIDE HAS BEEN VERY HOT. IT IS APPEARS THAT THE GENERATED HEAT HAS ORIGIN WITHIN THE DEVICE, HEATING THE OUTER SHELLS. THE SOURCE OF THE HEAT MOST LIKELY IS THE HYBRID, AND PROBABLY ALSO THE TRANSCIEVER MODULE. AN EXPERIMENT WITH THE 675 TYPE ZINC-AIR BATTERY USED IN THIS HEARING AID HAS BEEN CONDUCTED. A SHORT CIRCUIT TEST REVEALS ONLY AN TEMPERATURE INCREASE OF LESS THAN 3 DEGREE CELCIUS. FURTHERMORE IT IS NOT POSSIBLE FOR THE ZINC-AIR BATTERY TO RELEASE THE AMOUNT OF ENERGY NEEDED FOR A HEATING CAUSING THIS KIND OF DAMAGE. CONCLUSION: THE OUTER SHELL HAS CLEAR SIGNS OF HEAT FROM WITHIN. THE OUTER SHELL IS GREATLY DAMAGED. WHICH POINTS TO A HIGH AMOUNT OF ENERGY BEING RELEASED. THE ZINC-AIR BATTERY THAT IS POWERING THIS TYPE OF HEARING AID IS NOT CAPABLE OF DELIVERING THE KIND OF ENERGY THAT HAS CAUSED THIS DAMAGE. FURTHERMORE, A SHORT CIRCUIT TEST HAS BEEN CONDUCTED THAT SHOWS THE TEMPERATURE RISE THAT CAN BE EXPECTED, IF A SAFETY FAILURE WAS TO OCCUR. THE TEMPERATURE RISE WAS WITHIN 2-3 DEGREES. THERE IS A HIGH INDICATION THAT THE DEVICE HAS BEEN EXPOSED TO A MICROWAVE OVEN. THIS IS CONFIRMED WHEN COMPARING THE DEVICE TO TWO REFERENCE DEVICES THAT HAVE BEEN EXPOSED TO A MICROWAVE OVEN. THEY SHOW SIMILAR SIGNS OF DAMAGE. FINAL REPORTABILITY: BASED ON THE CLINICAL ASSESSMENT, TECHNICAL INVESTIGATION AND RISK REGISTER INFORMATION THE CASE OF DEVICE MALFUNCTION IS REPORTABLE, AS IT IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. INTERNAL INVESTIGATION CONCLUDES THAT THE DEVICE HAS BEEN EXPOSED TO EXTERNAL HEAT AND THERE HAS BEEN NO ISSUES DURING MANUFACTURE OF THE DEVICE.
(B)(4). EVENT REPORTED AS - OVERHEATED. HEARING AID IS MELTED - BURNED BADLY- NO PATIENT HARM HAS OCCURRED.
MDR 3005650109-2022-00009_ SF 2383311_FINAL. EVENT REPORTED AS - OVERHEATED. HEARING AID IS MELTED - BURNED BADLY- NO PATIENT HARM HAS OCCURRED. 25JUL2022: NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. ADVERSE EVENT IS UNTICKED AS THERE WAS NO PATIENT HARM. THIS IS A FINAL REPORT UPDATED WITH DEVICE INVESTIGATIONS. NO FURTHER INFORMATION IS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2280698 | KE398-DW,KEY 3,GN RESOUND | HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY | OSM | GN HEARING A/S | 21630605 | 05708296209736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |