HEADBAND HB-7 FOR TDH39
Report
- Report Number
- 9612197-2020-00011
- Event Type
- Malfunction
- Date Received
- September 17, 2020
- Date of Event
- September 7, 2020
- Report Date
- September 10, 2020
- Manufacturer
- NATUS MEDICAL DENMARK
- Product Code
- EWO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
UPDATE 15 OCT 2020 (FOLLOW UP 001) REF COMPLAINT# (B)(4). INVESTIGATION ON THE RETURNED PART IS UNDERWAY. ON INITIAL INSPECTION THERE IS A CRACK VISIBLE. FURTHER INVESTIGATION IS REQUIRED.
UPDATE 13 NOV 2020 (FOLLOW UP 002) REF COMPLAINT# (B)(4). THE PART WAS RETURNED FOR EVALUATION. (B)(4)- COMPLAINT INVESTIGATION REPORT IS CURRENTLY UNDER REVIEW AND DOCUMENTS THE FOLLOWING: THE ROOT CAUSE OF THE HEADSET BREAKING 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 BREAKING 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. RECOMMENDED ACTIONS: TIG RECOMMENDS UPDATING THE USER GUIDE, TO INCLUDE A SENTENCE STATING THAT THE ACOUSTICIAN SHOULD INSPECT THE HEADSET FOR ANY DAMAGE BEFORE USING IT ON A PATIENT, TO AVOID USING THE HEADSET WITH A BROKEN HEADSET. REVIEW AND FINAL APPROVAL OF INVESTIGATION RESULTS IS REQUIRED BEFORE CLOSURE OF THIS REPORT.
11 DEC 2020 (FOLLOW UP 003) REF COMPLAINT#(B)(4). DOC-050766 REV A- COMPLAINT INVESTIGATION REPORT DOCUMENTS THE FOLLOWING: TIG RECEIVED THE HEADSET BACK FROM THE FIELD FOR INVESTIGATION. A QUICK INSPECTION OF THE HEADSET SHOWS THAT THE PLASTIC AROUND THE EAR HOOK IS BROKEN. THE HEADSET HAVE BEEN IN USE SINCE 2013. TESTING AND INVESTIGATION RESULTS: FORCE-TEST: MOUNTED THE NONE-BROKEN SIDE OF THE HEADSET TO A FIXED FIXTURE AND FORCE GAUGES CONNECTED TO THE SIDE WITH THE CRACKED PLASTIC. PRESSURE IS SLOWLY APPLIED PULLING THE FORCE GAUGE STRETCHING THE HEADSET FROM ITS NORMAL POSITION 1 TO POSITION 2. IT WAS POSSIBLE TO STRETCH THE HEADSET 23-24 CM BEFORE THE EAR HOOK BROKE OFF THE HEADBAND AS THE CUSTOMER EXPLAINED. THE FORCE GAUGE SHOWED 14 NEWTON'S AT THE MAXIMUM POSITION, CONVERTING THE VALUE TO KG AND WE GET A VALUE OF 1.4276 KILOGRAM-FORCE. THIS SHOWS THAT A GOOD AMOUNT OF FORCE IS NEEDED TO BREAK OFF THE EAR HOOK, WHEN THE PLASTIC IS BROKEN. THE CUSTOMER EXPLAINS THAT THE HEADSET EAR HOOK WAS AT THE MAXIMUM EXTENDED POSITION WHEN IT BROKE. FORCE-TEST OTHER SIDE. PERFORMED THE FORCE TEST WITH THE SAME HEADSET, THIS TIME THE BROKEN SIDE WAS MOUNTED TO THE FIXED FIXTURE AND FORCE GAUGES CONNECTED TO THE NONE-BROKEN SIDE. PRESSURE IS SLOWLY APPLIED PULLING THE FORCE GAUGE STRETCHING THE HEADSET AS MUCH AS POSSIBLE, HERE IT WAS NOT POSSIBLE TO BREAK THE EAR HOOK OFF THE HEADBAND. THE FORCE-GAUGE SHOWED 90 NEWTON, CONVERTING THE VALUE TO KG AND WE GET A VALUE OF 9.1774 KILOGRAM-FORCE, THIS SHOWS THAT A SUBSTANTIAL AMOUNT OF FORCE IS APPLIED WITHOUT CRACKING THE PLASTIC. WE INVESTIGATED OTHER METHODS OF BREAKING THE PLASTIC SURROUNDING THE EAR HOOK, THE TEST THAT SHOWED THE SAME DAMAGE AS THE CUSTOMERS WAS BY TWISTING THE EAR HOOK UNTIL THE PLASTIC BROKE RELEASING THE EAR HOOK FROM ITS GRIP AND WHERE THE PLASTICS BROKEN, WHEN COMPARING IT WITH THE CUSTOMERS ITS ALMOST IDENTICAL, A LONG TEAR ALONG THE INNER SIDE OF THE PLASTICS OBSERVED. WE ALSO NOTICED THAT THE PLASTIC GRIP AROUND THE EAR HOOK IS LOOSENED CAUSING THE EAR HOOK TO SLIDE EASILY UP AND DOWN AND THIS IS NOT THE CASE WHEN THE PLASTICS UNBROKEN. CONTACTED THE HEADSET MANUFACTURING COMPANY WILFAN IN ORDER TO INVESTIGATE IF THE USE OF ALCOHOL DISINFECTANT WOULD MAKE THE PLASTIC BRITTLE AROUND THE EAR HOOK, WHAT THE PRODUCT LIFESPAN IS FOR THE HEADBAND AND IF THE PLASTIC MATERIAL HAS CHANGED OVER TIME. THE FOLLOWING REPLIES WERE RECEIVED: 1) THE PLASTIC IS POM, ALSO CALLED ACETAL. THE ENGINEER/ DESIGNER MENTIONED THAT ACCORDING TO THE CHEMICAL COMPATIBILITY CHART, ALCOHOL SHOULD NOT AFFECT THE PLASTIC. 2) PRODUCT LIFESPAN - A CYCLE TESTING WAS NEVER DONE. ENGINEERING WILL ADD IT TO THE VALIDATION OF THE NEW PROCESS. THEY NOTED THAT THE ITEM HAS A 1-YEAR WARRANTY SINCE DAY OF PURCHASE. 3) AS FAR AS THEY HAVE BEEN ABLE TO VERIFY, THE MATERIAL HAS NOT CHANGED. HOWEVER, THEY MANUFACTURE ITEMS OUTSIDE OF HEADQUARTERS AND VERIFICATION HAS NOT BEEN DONE BY SOMEONE IN HEADQUARTERS YET. THE ROOT CAUSE OF THE HEADSET BREAKING 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 BREAKING 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 BREAK 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. THE CURRENT RISK FILE 7-38-00143 REV 08 HAZARD ID 6.8. HARM - USER & PATIENT INJURY. CAUSE- "INADEQUATE DESIGN -[DEVICE HAS ROUGH, SURFACE AND/OR SHARP CORNERS &/OR EDGES]." SEVERITY- MARGINAL (3). RISK LEVEL- NEGLIGIBLE (0). 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. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS ((B)(4)) CORPORATE TRENDING AND ANALYSIS PROCEDURE ) AND ANY COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. NO TREND FOR THIS DEVICE IDENTIFIED. RECOMMENDED ACTIONS: TIG RECOMMENDS UPDATING THE USER GUIDE, TO INCLUDE A SENTENCE STATING THAT THE ACOUSTICIAN SHOULD INSPECT THE HEADSET FOR ANY DAMAGE BEFORE USING IT ON A PATIENT, TO AVOID USING THE HEADSET WITH A BROKEN HEADSET.
WHEN PUTTING ON THE HEADPHONES, THEY BROKE INTO 2 PARTS. PATIENT RECEIVED A SMALL OPEN WOUND ON THE FOREHEAD, WHICH WAS DISINFECTED ON SITE AND A PLASTER PLACED ON THE CUT.
WHEN PUTTING ON THE HEADPHONES, THEY BROKE INTO 2 PARTS. PATIENT RECEIVED A SMALL OPEN WOUND ON THE FOREHEAD, WHICH WAS DISINFECTED ON SITE AND A PLASTER PLACED ON THE CUT.
WHEN PUTTING ON THE HEADPHONES, THEY BROKE INTO 2 PARTS. PATIENT RECEIVED A SMALL OPEN WOUND ON THE FOREHEAD, WHICH WAS DISINFECTED ON SITE AND A PLASTER PLACED ON THE CUT.
CUSTOMER HAS BEEN REQUESTED TO RETURN THE DEVICE FOR EXAMINATION.
WHEN PUTTING ON THE HEADPHONES, THEY BROKE INTO 2 PARTS. PATIENT RECEIVED A SMALL OPEN WOUND ON THE FOREHEAD, WHICH WAS DISINFECTED ON SITE AND A PLASTER PLACED ON THE CUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1015995 | HEADBAND HB-7 FOR TDH39 | HEADBAND HB-7 FOR TDH39 | EWO | NATUS MEDICAL DENMARK | 1-25-12200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |