FDA Adverse Event Injury Summary report: N

MAXILIFT SIZE L

MDR report key: 8796 · Received July 26, 1994

Report

Report Number: 8796
Event Type: Injury
Date Received: July 26, 1994
Date of Event: July 18, 1994
Report Date: July 22, 1994
Manufacturer: ARJO-CENTURY, INC.
Product Code: FSA
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

WHILE GETTING PT UP TO CHAIR USING LIFT, STRAPS ON SLING BROKE AND PT FELL.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAXILIFT SIZE L	CHAIR LIFT SEAT	FSA	ARJO-CENTURY, INC.	102124

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Required Intervention