UNITRON D MOXI JUMP R CHARGER
Report
- Report Number
- 3005085999-2024-00005
- Event Type
- Malfunction
- Date Received
- February 8, 2024
- Report Date
- January 18, 2024
- Manufacturer
- SONOVA AG
- Product Code
- OSM
- UDI-DI
- 07613389386868
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DEVICE IS REQUESTED TO BE SENT BACK FOR ANALYSIS.
AT THE TIME OF THE INCIDENT THE CHARGER HAS BEEN USED WITH AN OPTIONAL ACCESSORY UNITRON POWER PACK AND MOXI B9-R HEARING AIDS. THE CURRENT REPORT IS THE FIRST INSTANCE OF THIS MALFUNCTION THAT SONOVA AG HAS BECOME AWARE OF. THE MANUFACTURER HAS PERFORMED VISUAL INSPECTION AND A CT SCAN TO DETERMINE THE ROOT CAUSE OF IGNITION. THE DEVICE INVESTIGATION HAS SHOWN THAT THE FIRE STARTED IN THE SYSTEM AS A RESULT OF A THERMAL RUNAWAY IN THE BATTERY OF THE UNITRON POWER PACK. THERMAL RUNAWAY IS AN INHERENT RISK OF LITHIUM-BASED BATTERY TECHNOLOGY, AND CAN BE TRIGGERED BY VARIOUS FACTORS. THE ROOT CAUSE OF THE EVENT COULD SO FAR NOT BE IDENTIFIED. THE INVESTIGATION IS ONGOING. THE RISK ASSESSMENT WILL BE UPDATED BASED ON THE CONCLUSIONS OF THE INVESTIGATION. INSTRUCTIONS FOR USE CONTAIN A SET OF RECOMMENDATIONS FOR THE SAFE USE OF THE CHARGER AND POWER PACK, INCLUDING THE RANGE OF ACCEPTABLE ENVIRONMENTAL CONDITIONS AND COMPATIBLE CHARGING ACCESSORIES.
AT THE TIME OF THE INCIDENT THE CHARGER HAS BEEN USED WITH AN OPTIONAL ACCESSORY UNITRON POWER PACK AND MOXI B9-R HEARING AIDS. THE CURRENT REPORT IS THE FIRST INSTANCE OF THIS MALFUNCTION THAT SONOVA AG HAS BECOME AWARE OF SINCE 2022. THE MANUFACTURER HAS PERFORMED VISUAL INSPECTION AND A CT SCAN TO DETERMINE THE ROOT CAUSE OF IGNITION. THE DEVICE INVESTIGATION HAS SHOWN THAT THE FIRE STARTED IN THE SYSTEM AS A RESULT OF A THERMAL RUNAWAY IN THE BATTERY OF THE UNITRON POWER PACK. THERMAL RUNAWAY IS AN INHERENT RISK OF LITHIUM-BASED BATTERY TECHNOLOGY, AND CAN BE TRIGGERED BY VARIOUS FACTORS. THE REXACT OOT CAUSE OF THE EVENT COULD NOT BE IDENTIFIED.THE INVESTIGATION IS ONGOING. INSTRUCTIONS FOR USE CONTAIN A SET OF RECOMMENDATIONS FOR THE SAFE USE OF THE CHARGER AND POWER PACK, INCLUDING THE RANGE OF ACCEPTABLE ENVIRONMENTAL CONDITIONS AND COMPATIBLE CHARGING ACCESSORIES. OBSERVED RESIDUAL RISK ACCORDING TO POLICY POL-54 IS "LOW RISK," ALL RELATED RISKS ARE CONSIDERED AND REDUCED AS FAR AS POSSIBLE.
IT HAS BEEN REPORTED THAT A UNITRON D MOXI JUMP R CHARGER HAS CAUGHT FIRE AT NIGHT WHILE CHARGING THE HEARING AIDS AND LEAD TO SOME DAMAGE TO FURNITURE AND THE WALL IN CLOSE PROXIMITY OF THE DEVICE. UPON FOLLOW-UP, THE USER HAS CONFIRMED THAT HE HAS RECEIVED A MINOR BURN DUE TO THE INCIDENT. THE CUSTOMER HAS RECEIVED A REPLACEMENT OF THE CHARGER AND HEARING AIDS. THE DEVICE HAS NOT SO FAR BEEN RECEIVED BUT HAS CURRENTLY BEEN REQUESTED BY MANUFACTURER FOR FURTHER ANALYSIS. THIS IS AN INITIAL REPORT. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION.
IT HAS BEEN REPORTED THAT A UNITRON D MOXI JUMP R CHARGER HAS CAUGHT FIRE AT NIGHT WHILE CHARGING THE HEARING AIDS AND LEAD TO SOME DAMAGE TO FURNITURE AND THE WALL IN CLOSE PROXIMITY OF THE DEVICE. UPON FOLLOW-UP, THE USER HAS CONFIRMED THAT HE HAS RECEIVED A MINOR BURN DUE TO THE INCIDENT. THE CUSTOMER HAS RECEIVED A REPLACEMENT OF THE CHARGER AND HEARING AIDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1366104 | UNITRON D MOXI JUMP R CHARGER | UNITRON D MOXI JUMP R CHARGER | OSM | SONOVA AG | 075584612 | 07613389386868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |