FDA Adverse Event Malfunction Summary report: N

ENTERPRISE 8000

MDR report key: 2670971 · Received July 19, 2012

Report

Report Number: 3007420694-2012-00020
Event Type: Malfunction
Date Received: July 19, 2012
Date of Event: June 19, 2012
Report Date: June 19, 2012
Manufacturer: ARJOHUNTLEIGH POLSKA SP. ZO.O.
Product Code: FNL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
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 PARTS THE CUSTOMER IS REFERRING TO ARE COVERS AND INTEGRAL PART OF THE DESIGN OF THE SAFETY SIDES, THE COVERS ARE USED AS MEANS COVERING THE RECESS CAUSED BY MOUNTING THE HINGE JOINT OF THE SAFETY SIDE, TO ALLEVIATE SOME OF A DIRT TRAPS AND THE INGRESS OF FLUIDS INTO THE RECESS BY GIVING THE ASSEMBLY, ONE OUTER SURFACE IN AREA OF THE HINGE MOUNTING COVERING FASTENERS, HINGE PINS ETC. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

Description of Event or Problem · 1

ENTERPRISE 8000 BED SAFETY SIDES - THE MIDDLE BIT IS EASY TO CLEAN AS IT CAN BE UNCLIPPED AND REMOVED FOR CLEANING, THE SMALLER PARTS DO NOT COME OFF, SO CLEANING IS DIFFICULT - AN INFECTION CONTROL RISK HAS BEEN IDENTIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENTERPRISE 8000	MEDICAL BED	FNL	ARJOHUNTLEIGH POLSKA SP. ZO.O.	8000DA22A12BA

Patients

Seq	Age	Sex	Outcome	Treatment
1