AURICAL AUD/PMM, 1081
Report
- Report Number
- 9612197-2020-00012
- Event Type
- Malfunction
- Date Received
- September 23, 2020
- Date of Event
- September 7, 2020
- Report Date
- September 8, 2020
- Manufacturer
- NATUS MEDICAL DENMARK
- Product Code
- EWO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
UPDATE 22 OCT 2020 (FOLLOW UP 001) REF #(B)(4). DEVICE WAS RETURNED FOR REPAIR AND THE FOLLOWING WAS NOTED: NO POWER - NOT POSSIBLE TO CONNECT . DEFECTS USB BLUETOOTH DONGLE REPLACED WITH NEW. AURICAL AUD REPLACED WITH NEW ATO. CALIBRATION OFFSET PROVIDED AND UPLOADED TO NEW UNIT. FUNCTION AND FINAL TEST PERFORMED. CAPA004844 HAS BEEN GENERATED. SUMMARY OF ACTIONS TAKEN TODATE: POST MARKET RECORD, UPDATED TO INCLUDE 1081 AURICAL AUD. RISK ANALYSIS DOCUMENT 7-38-00143 UPDATED TO INCLUDE RISK OF LOST USB CONNECTION DUE TO COMPONENT FAILURE - NEW HAZARD ID 5.41 (RAS+RBA TAPS) HAS BEEN IMPLEMENTED. STATUS OF CAPA004844 IS CURRENTLY AT ROOT CAUSE INVESTIGATION.
UPDATE 20 NOV 2020 (FOLLOW UP 002) REF #(B)(4). CAPA004844 WAS GENERATED AND IS CURRENTLY AT CAPA PLAN. POST MARKET RECORD DOC-046429 REV 02 HAS BEEN UPDATED TO INCLUDE 1081 AURICAL AUD. INVESTIGATION FINDINGS: COMPLAINT INVESTIGATION REPORT DOC-045830 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.
ON 15 JANUARY 2021 (FOLLOW UP 003) (REF NATUS COMPLAINT#: (B)(4)). (B)(4) 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 (B)(4) 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.
THE PC SHOWED THE "USB OVERVOLTAGE" MESSAGE, BUT DEVICE CONTINUED WORKING. SUDDENLY THE DEVICE DISCONNECTED AND OTOAIR BECAME MELTED. NO PATIENT INVOLVEMENT.
THE PC SHOWED THE "USB OVERVOLTAGE" MESSAGE, BUT DEVICE CONTINUED WORKING. SUDDENLY THE DEVICE DISCONNECTED AND OTOAIR BECAME MELTED. NO PATIENT INVOLVEMENT.
THE PC SHOWED THE "USB OVERVOLTAGE" MESSAGE, BUT DEVICE CONTINUED WORKING. SUDDENLY THE DEVICE DISCONNECTED AND OTOAIR BECAME MELTED. NO PATIENT INVOLVEMENT.
ON 23 SEPT 2020, (REF NATUS COMPLAINT#: (B)(4)). NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. ALL COMPONENTS OF THE DEVICE HAVE BEEN REQUESTED TO BE RETURNED FOR EVALUATION.
THE PC SHOWED THE "USB OVERVOLTAGE" MESSAGE, BUT DEVICE CONTINUED WORKING. SUDDENLY THE DEVICE DISCONNECTED AND OTO AIR BECAME MELTED. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1042229 | AURICAL AUD/PMM, 1081 | AURICAL AUD/PMM, 1081 | EWO | NATUS MEDICAL DENMARK | 8-04-14500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |