HEADSET HB-7 (12 KHZ) MATCHED TDH39 PHONES (JACK)
Report
- Report Number
- 9612197-2022-00007
- Event Type
- Malfunction
- Date Received
- April 22, 2022
- Date of Event
- April 11, 2022
- Report Date
- November 4, 2022
- Manufacturer
- NATUS MEDICAL DENMARK APS
- Product Code
- EWO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORT REF COMPLAINT#(B)(4). THE CUSTOMER STATES A MORE SERIOUS INJURY COULD BE CAUSED IF THE HEADBAND WAS TO SPRING BACK AND CATCH THE PATIENT IN A MORE DELICATE AREA, SUCH AS NEARER THE EYE. ALL COMPONENTS OF THE DEVICE WILL BE RETURNED FOR EVALUATION. RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT). THE CURRENT RISK FILE 1081 AURICAL AUD & MADSEN A450 - RISK ANALYSIS - DOC-049635 REV 04 HAZARD ID 5.46 IDENTIFIES THIS ISSUE. HARM - MINOR INJURY TO THE PATIENT OR USER OR DISCOMFORT. CAUSE- MECHANICAL BREAKAGE, CAUSING SHARP CORNER, EDGES OR PINCH POINTS. E.G. DUE TO STEADY FORCE APPLIED ON THE DEVICE. (HIT BY SOMETHING). SEVERITY- MARGINAL (3). RISK LEVEL- MINOR (3). UDI - N/A. INSTALL DATE OF DEVICE: DATE: 9/1/2014.
FOLLOW UP REPORT 002 REF COMPLAINT#(B)(4). FEEDBACK FROM ENGINEERING: THE ISSUE IS FOUND TO BE SIMILAR TO A PREVIOUS INVESTIGATIONS DONE WITH A TDH39 HEADSET (DCO#45273) REF DOC-050766 REV A. THE FOLLOWING WAS DOCUMENTED AT THE TIME: ROOT CAUSE/PROBABLE ROOT CAUSE: THE ROOT CAUSE OF THE HEADSET BRAKING OFF IS THAT THE PLASTIC SURROUNDING THE EAR HOOK HAS CRACKED AND THIS CAUSES THE PLASTIC TO LOSE ITS STRENGTH TO HOLD ON THE EAR HOOK, WHEN PRESSURE IS APPLIED THE PLASTIC EXPANDS AND ALLOWS THE EAR HOOK TO SLIP OUT OF ITS GRIP. THE INVESTIGATION ALSO SHOWS THAT THE HEADBAND CAN WITHSTAND A BIG AMOUNT OF FORCE WITHOUT BRAKING THE EAR HOOK OFF WHEN THE PLASTIC IS INTACT AND USED IN THE CORRECT WAY, BUT THE INVESTIGATION ALSO SHOW THAT IT'S POSSIBLE TO BRAKE THE HEADSET IF IT'S USED INCORRECTLY FOR EXAMPLE TWISTING THE EAR HOOK. IT IS NOT POSSIBLE TO DETERMINE WHY THE PLASTIC BROKE BASED ON THIS SINGLE INVESTIGATION. FEEDBACK FROM OUR SUPPLIER: WE WARRANTY THE HEADSET FOR ONE YEAR, ALTHOUGH OUR HEADSETS NORMALLY HAVE A VERY LONG LIFE SPAN. UNFORTUNATELY, AS YOU HAVE EXPERIENCE, WE HAVE HAD SOME ISSUES WITH SOME HEADSETS IN PREVIOUS LOTS, WHICH IS NOT THE NORM FOR OUR PRODUCTS. WE'VE BEEN WORKING WITH OUR SUPPLIER ON THIS ISSUE FOR SOME TIME, AND WE'VE SEEN MUCH IMPROVEMENT IN THE HEADSETS, HOWEVER WE ARE PUSHING OUR SUPPLIER TO MAKE SURE WE'VE COVERED ANY AND ALL ISSUES. FAILLURE CONFIRMED:YES INVESTIGATION RESULT CODE: TAASTRUP/HEADBAND CLOSURE RATIONALE:COMPLAINT VERIFIED, CAPA INIATED OR ALREADY OPEN.
FOLLOW UP REPORT 001 REF COMPLAINT#(B)(4) HEADSET WAS RECEIVED BY TECHNICAL SERVICE AND SHIPPED TO TAASTRUP FOR FURTHER INVESTIGATION. AWAITING INVESTIGATION RESULTS. CAPA005378 HAS BEEN OPENED TO ADDRESS THIS DEFICIENCY WITH THE SUPPLIER. PER (B)(4), COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW (B)(4). NO TREND FOR THIS FAILURE IDENTIFIED DURING TRENDING 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. PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY. DHR WAS REVIEWED AND NO RELATED FAULTS/ISSUE FOUND. SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED PER (B)(4).
THE CUSTOMER WAS ABOUT TO PLACE THE HEADPHONES OVER THE PATIENT'S EARS TO PERFORM A HEARING TEST. AS THE HEADPHONES WERE OPENED TO PLACE IN POSITION THE PIN WHICH HOLDS THE LEFT CUP TO THE HEAD BAND SPRANG OUT OF ITS POSITION. THE LADY'S HEAD INITIALLY FELT TENDER, BUT THERE WAS NO BRUISE OR ABRASION.
THE CUSTOMER WAS ABOUT TO PLACE THE HEADPHONES OVER THE PATIENT'S EARS TO PERFORM A HEARING TEST. AS THE HEADPHONES WERE OPENED TO PLACE IN POSITION THE PIN WHICH HOLDS THE LEFT CUP TO THE HEAD BAND SPRANG OUT OF ITS POSITION. THE LADY'S HEAD INITIALLY FELT TENDER, BUT THERE WAS NO BRUISE OR ABRASION.
THE CUSTOMER WAS ABOUT TO PLACE THE HEADPHONES OVER THE PATIENT'S EARS TO PERFORM A HEARING TEST. AS THE HEADPHONES WERE OPENED TO PLACE IN POSITION THE PIN WHICH HOLDS THE LEFT CUP TO THE HEAD BAND SPRANG OUT OF ITS POSITION. THE LADY'S HEAD INITIALLY FELT TENDER, BUT THERE WAS NO BRUISE OR ABRASION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2005032 | HEADSET HB-7 (12 KHZ) MATCHED TDH39 PHONES (JACK) | HEADSET HB-7 (12 KHZ) MATCHED TDH39 PHONES (JACK) | EWO | NATUS MEDICAL DENMARK APS | 8-75-780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |