FDA Adverse Event Malfunction Summary report: N

MAXI PILLAR

MDR report key: 8804 · Received July 29, 1994

Report

Report Number: 8804
Event Type: Malfunction
Date Received: July 29, 1994
Date of Event: July 27, 1994
Report Date: July 29, 1994
Manufacturer: ARJO-CENTURY, INC.
Product Code: FSA
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

IN TRANSFERRING RESIDENT #82-684 FROM BED TO WHEELCHAIR, THE ARM SLING HOLDER SNAPPED. RESIDENT WAS 4" ABOVE CHAIR SEAT. RESIDENT FELL TO SEAT-NO INJURY.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-94. SERVICE PROVIDED BY: INDEPENDENT FACTORY TRAINED/AUTHORIZED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAXI PILLAR	PT LIFT-BATTERY POWERED	FSA	ARJO-CENTURY, INC.	MB0510

Patients

Seq	Age	Sex	Outcome	Treatment
1	99 YR		Other