FDA Adverse Event Malfunction Summary report: N

ENTERPRISE 8000

MDR report key: 2758195 · Received August 28, 2012

Report

Report Number: 3007420694-2012-00034
Event Type: Malfunction
Date Received: August 28, 2012
Date of Event: July 31, 2012
Report Date: July 31, 2012
Manufacturer: ARJOHUNTLEIGH POLSKA SP. ZO.O.
Product Code: FNL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). THE DEVICE WAS INSPECTED AT THE USER'S FACILITY BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. THIS THE SECOND TIME THE NURSING HOME HAS BROKEN/DAMAGED THIS BED IN THE SAME WAY, THE BED WAS REPAIRED AND RETURNED TO USE AFTER THE FIRST INCIDENT IN MAR 2011. AGAIN THE CENTRAL PIVOT SECTION HAS BEEN PULLED OUT OF THE DIECAST AND IT HAS TAKEN CONSIDERABLE FORCE TO FRACTURE IN THIS WAY. WE CANNOT SEE THAT THE CASTING WOULD FAIL IN THIS MANNER IN NORMAL USE AND FEEL THAT THE BED MUST HAVE BEEN SUBJECTED TO A SUBSTANTIAL IMPACT AS TYPICALLY THE TENSILE STRENGTH OF THIS HINGE MATERIAL IS 280N/MM2. WE CONCLUDED THAT THE FAILURE HAS BEEN CAUSED BY A SUBSTANTIAL IMPACT, WHICH IS CATEGORIZED AS MISUSE OF THE PRODUCT; (B)(4). OTHER THAN THE ACTIONS ALREADY TAKEN, THERE ARE NO FURTHER ACTIONS PROPOSED AT THIS TIME. THE MFR SHALL CONTINUE TO MONITOR ANY FURTHER INCIDENTS OF THIS NATURE TO DETERMINE TRENDING. THEREFORE AS THIS APPEARS TO BE AN ISOLATED INCIDENT WE CONSIDER THE CASE CLOSED.

Description of Event or Problem · 1

CUSTOMER ADVISED THAT THE HEADREST WOULD TWIST WHENEVER THE HEAD END OF THE BED WAS RAISED. TECH FOUND THAT THE HINGE ON THE BACKREST FRAME WAS BROKEN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENTERPRISE 8000	MEDICAL BED	FNL	ARJOHUNTLEIGH POLSKA SP. ZO.O.	8000BE42A22LA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other