1053 OTOAIR BLUETOOTH DONGLE
Report
- Report Number
- 9612197-2020-00006
- Event Type
- Malfunction
- Date Received
- March 7, 2020
- Date of Event
- February 23, 2020
- Report Date
- February 28, 2020
- Manufacturer
- NATUS MEDICAL DENMARK
- Product Code
- EWO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
09 SEPT 2020 ((FOLLOW UP 007) CAPA004844 HAS BEEN GENERATED AND CURRENTLY AT CAPA PLAN STATUS. CORRECTIVE ACTION PLAN: POST MARKET RECORD, TO BE UPDATED TO INCLUDE 1081 AURICAL AUD. UPDATE 1081 RISK ANALYSIS DOCUMENT IF NECESSARY, TO INCLUDE RISK OF LOST USB CONNECTION DUE TO COMPONENT FAILURE. PREVENTIVE ACTION PLAN: NO PREVENTIVE ACTION PLAN - THE FINAL ROOT CAUSE CONCLUSION FROM COMPLAINT INVESTIGATION REPORT AND THE JABRA INVESTIGATION IS THAT THE ROOT CAUSE CANNOT BE FOUND, BASED ON THE AVAILABLE INFORMATION. ROOT CAUSE HAS NOT BEEN DETERMINED. BASED ON INVESTIGATION RESULTS, NO FURTHER COMPLAINTS REPORTED AND PATIENT/USER RISK DETERMINED AS FAR AS POSSIBLE, NO FURTHER INVESTIGATION WILL BE PERFORMED. EFFECTIVITY CHECK PLAN TO BE CARRIED OUT ON CAPA004844.
UPDATE 29 APRIL 2020 (FOLLOW UP 002). THE DEVICE WAS RETURNED TO DENMARK FOR INVESTIGATION. TODATE, THIS INVESTIGATION HAS NOT BEEN CARRIED OUT.
UPDATE 19 JUNE 2020 (FOLLOW UP 004). CAPA004844 HAS BEEN OPENED TO INVESTIGATE THIS ISSSUE FURTHER. A PRE-INVESTIGATION HAS BEEN INITIATED FROM ENGINEERING. DEFECTIVE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004844 BEFORE CLOSURE.
UPDATE 16 JULY 2020 (FOLLOW UP 005). INVESTIGATION AND FINDINGS: CAPA004844 HAS BEEN OPENED TO INVESTIGATE THIS ISSUE FURTHER. THE DEFECTIVE DEVICE WAS RETURNED AND THE FOLLOWING WAS NOTED POST INVESTIGATION: THE PROBLEM DOES NOT SEEM TO BE RELATED TO U1 (BLUECORE) OR U11 (TRANSCEIVER) NOR THE CAPACITORS CONNECTED TO THE VDD_3V3 NETWORK. THE DEVICE USED 5.3 MA WHEN CONNECTED TO 5V ON VBUS AND DID NOT GET WARM. THERE WAS NO VOLTAGE ON THE OUTPUT OF THE 3V3 LDO (U3). THE VDD_3V3 NET (3.3 VDC POWER SUPPLY TO ELECTRONIC CIRCUIT) SEEMS TO BE "SHORTED". IT HAS BEEN MEASURED 500 - 1K OHMS RESISTANCE TO GND. RISK ASSESSMENT TO BE UPDATED TO INCLUDE LOST CONNECTION TO AURICAL AUD. NO ROOT CAUSE CONCLUSION TO DATE. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004844 BEFORE CLOSURE.
UPDATE 28 MAY 2020 (FOLLOW UP 003) CAPA004844 HAS BEEN OPENED TO INVESTIGATE THIS ISSSUE FURTHER. A PRE-INVESTIGATION HAS BEEN INITIATED FROM ENGINEERING. DEFECTIVE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION.
UPDATE 14 AUG 2020 (FOLLOW UP 006). CAPA004844 HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. THE FINAL ROOT CAUSE CONCLUSION FROM COMPLAINT INVESTIGATION REPORT AND THE JABRA INVESTIGATION IS THAT THE ROOT CAUSE CANNOT BE FOUND, BASED ON THE AVAILABLE INFORMATION. FINAL INFORMATION TO BE DOCUMENTED AND A EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004844 BEFORE CLOSURE.
04 NOV 2020 ((FOLLOW UP 009) REF #: (B)(4). CAPA004844 WAS GENERATED AND IS CURRENTLY AT CAPA PLAN. POST MARKET RECORD (B)(4) REV 02 HAS BEEN UPDATED TO INCLUDE 1081 AURICAL AUD. INVESTIGATION FINDINGS: COMPLAINT INVESTIGATION REPORT (B)(4) REV B WAS COMPLETED. PROBABLE ROOT CAUSE: BASED ON FOUR CASES, WE BELIEVE THAT AT SOME POINT, EITHER U17 OR U20 (ISOLATED VOLTAGE REGULATOR), FAILS AND THEN OUTPUTS MORE THAN 5V. THIS EXTENSIVE VOLTAGE CAN THEN CAUSE A FAILURE OF OTHER COMPONENTS. IN CASE THE USER HAS OTOAIR ON USB_1, FAILURE OF U17 CAN DAMAGE THIS COMPONENT, AND WHILE IT IS DAMAGED, IT GENERATES A HEAT AND CAUSES THE SHELL OF OTOAIR TO DEFORM. SIMILARLY, IN CASE THE OTOAIR IS ON USB_2 OR USB_3 AND U20 FAILS, THAT AGAIN CAN CAUSE DAMAGE TO OTOAIR. IN THE CASE OF U17 BREAKS, IT WILL CAUSE DAMAGE TO THE MAIN CIRCUIT OF AUD. IN ANY OF THE SITUATIONS, SINCE THERE IS A SHORT CIRCUIT, THE THERMISTOR BLOCKS THE CURRENT AND THE WHOLE DEVICE BECOMES DEFECTIVE. U17 AND U20 GENERATE A LOT OF HEAT WHILE THEY ARE WORKING, EVEN IN IDLE STATE. THE DESIGN OF THE AUD HOUSING IS SO THAT IT ALLOWS ALMOST NO AIR CIRCULATION, AND CONSEQUENTLY THE AMBIENT TEMPERATURE AROUND THESE COMPONENTS GETS ELEVATED. WE BELIEVE THAT THE ELEVATED HEAT CAN CAUSE THESE TWO COMPONENTS TO GET DEFECT BEFORE THEIR EXPECTED LIFETIME. THE DEFECT AUD DEVICES ARE HOWEVER ALL FROM 2012, WHICH MEANS THAT THEY HAVE HAD A LIFETIME OF 8 YEARS, WHICH IS BEYOND THE SPECIFIED LIFETIME OF 5 YEARS FOR THE AURICAL AUD DEVICE. CAPA PLAN AND ACTIONS TO BE REVIEWED AND APPROVED.
06 NOV 2020 ((FOLLOW UP 008) REF #(B)(4). CAPA004844 WAS GENERATED AND HAS RETURNED TO ROOT CAUSE INVESTIGATION STATUS. CORRECTIVE ACTION PLAN: 1) POST MARKET RECORD, TO BE UPDATED TO INCLUDE 1081 AURICAL AUD. 2) UPDATE OF 1081 RISK ANALYSIS DOCUMENT 7-38-00143, TO INCLUDE RISK OF LOST USB CONNECTION DUE TO COMPONENT FAILURE. CORRECTIVE ACTIONS COMPLETED: 1) DOC-046429 POST MARKET RECORD, HAS BEEN IMPLEMENTED ON DCO#44038. 2) 1081, RISK ANALYSIS DOCUMENT 7-38-00143 HAS BEEN UPDATE WITH NEW HAZARD ID 5.41 (RAS+RBA TAPS) AND WAS IMPLEMENTED ON DCO#44103. DOC-045830 COMPLAINT INVESTIGATION REPORT IS CURRENTLY BEEN REVISED TO INCLUDE NEW INFORMATION.
20 JANUARY 2021 (FOLLOW UP 010) REF #1-705837281. DOC-045830 REV B COMPLAINT INVESTIGATION REPORT HAS BEEN RELEASED AND STATES THE FOLLOWING: ROOT CAUSE/PROBABLE ROOT CAUSE: BASED ON FOUR CASES, WE BELIEVE THAT AT SOME POINT, EITHER U17 OR U20 (ISOLATED VOLTAGE REGULATOR), FAILS AND THEN OUTPUTS MORE THAN 5V. THIS EXTENSIVE VOLTAGE CAN THEN CAUSE A FAILURE OF OTHER COMPONENTS. IN CASE THE USER HAS OTOAIR ON USB_1, FAILURE OF U17 CAN DAMAGE THIS COMPONENT, AND WHILE IT IS DAMAGED, IT GENERATES A HEAT AND CAUSES THE SHELL OF OTOAIR TO DEFORM. SIMILARLY, IN CASE THE OTOAIR IS ON USB_2 OR USB_3 AND U20 FAILS, THAT AGAIN CAN CAUSE DAMAGE TO OTOAIR. IN THE CASE OF U17 BREAKS, IT WILL CAUSE DAMAGE TO THE MAIN CIRCUIT OF AUD. IN ANY OF THE SITUATIONS, SINCE THERE IS A SHORT CIRCUIT, THE THERMISTOR BLOCKS THE CURRENT AND THE WHOLE DEVICE BECOMES DEFECTIVE. U17 AND U20 GENERATE A LOT OF HEAT WHILE THEY ARE WORKING, EVEN IN IDLE STATE. THE DESIGN OF THE AUD HOUSING IS SO THAT IT ALLOWS ALMOST NO AIR CIRCULATION, AND CONSEQUENTLY THE AMBIENT TEMPERATURE AROUND THESE COMPONENTS GETS ELEVATED. WE BELIEVE THAT THE ELEVATED HEAT CAN CAUSE THESE TWO COMPONENTS TO GET DEFECT BEFORE THEIR EXPECTED LIFETIME. THE DEFECT AUD DEVICES ARE HOWEVER ALL FROM 2012, WHICH MEANS THAT THEY HAVE HAD A LIFETIME OF 8 YEARS, WHICH IS BEYOND THE SPECIFIED LIFETIME OF 5 YEARS FOR THE AURICAL AUD DEVICE. RECOMMENDED ACTIONS: NO RECOMMENDED ACTIONS NOW. IF A MAJOR REDESIGN OF THE DEVICE HARDWARE DONE IN THE FUTURE, IT IS RECOMMENDED TO REPLACE THE PRESENT ISOLATED VOLTAGE REGULATORS, U17 AND U20 WITH A TYPE WITH LOWER IDLE POWER CONSUMPTION. RISK ASSESSMENT/HEALTH HAZARD EVALUATIN - POST MARKET RECORD DOC-046429 REV 02 HAS BEEN UPDATED TO INCLUDE 1081 AURICAL AUD. 1081 RISK ANALYSIS DOCUMENT 7-38-00143 HAS BEEN UPDATED TO INCLUDE HAZARD ID 5.41 WITH REFERENCE TO RISK OF LOST USB CONNECTION DUE TO COMPONENT FAILURE. BASED ON THE RISK EVALUATION IT DETERMINES THE OVERALL RISK TO BE MINOR AND THE AGE OF THE ASSOCIATED DEVICES WHICH HAS SHOWN TO BE BEYOND THE SPECIFIED PRODUCT LIFETIME OF THE AURICAL AUD DEVICE, IT WAS RECOMMENDED THAT THIS CAPA IS CLOSED WITH NO CORRECTIVE/PREVENTIVE ACTIONS. COMPLAINTS WITH SIMILAR SYMPTOM/FAILURE MODE WILL BE MONITORED AND PROCESSED AS PER QMS-000050 COMPLAINT HANDLING PROCEDURE.
UPDATE (B)(6)2020. THIS INCIDENT OCCURRED AS THE PC WAS BEING REPLACED AND IT IDENTIFIED A POWER SURGE FROM THE AURICAL. UPON REMOVING THE COVER OF THE FREEFIT SPEAKER REVEALED A MELTED OTOAIR WAS IDENTIFIED. THE OTOAIR WAS PLUGGED IN BEHIND THE FREEFIT SPEAKER. PRODUCT HAS NOT BEEN RETURNED TO DATE FOR EVALUATION. INVESTIGATION PENDING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
CUSTOMER REPORTS AN ISSUE WHERE ONE OF THEIR OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
PATIENT INFORMATION: NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. RELEVANT TESTS / LABORATORY DATA: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS: NOT APPLICABLE. IF IMPLANTED DATE (MM/DD/YYYY): THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY): THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS: THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT): THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL #: THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS: THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED, CHECK TYPE: THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER: THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).
CUSTOMER REPORTS AN ISSUE WHERE ONE OF THEIR OTOAIR DONGLES HAS STARTED TO MELT BEHIND THE FREEFIT SPEAKER AND STOPPED WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267093 | 1053 OTOAIR BLUETOOTH DONGLE | 1053 OTOAIR BLUETOOTH DONGLE | EWO | NATUS MEDICAL DENMARK | 8-62-41503 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |