FDA Adverse Event Injury Summary report: N

WHEELCHAIR

MDR report key: 7944 · Received March 31, 1994

Report

Report Number: 7944
Event Type: Injury
Date Received: March 31, 1994
Date of Event: March 22, 1994
Report Date: March 31, 1994
Manufacturer: EVEREST & JENNINGS, INC.
Product Code: IOR
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

RESIDENT FOUND ON FLOOR IN SHOWER ROON LYING ON RIGHT SIDE. RESIDENT STATES HE WAS TRANSFERRING FROM SHOWER CHAIR TO WHEELCHAIR AND WHEELCHAIR MOVED BACKWARDS, CAUSING RESIDENT TO FALL. OBSERVATION BY NURSING STAFF NOTED THAT WHEELCHAIR WAS LOCKED IN POSITION BUT WHEELS CONTINUED TO MOVE. INCIDENT NOT WITNESSED, RESIDENT NOT WEARING FOOTWEAR OR SOCKS, AND FLOOR PITCHED DUE TO DRAINAGE.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-SEP-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS NOT AVAILABLE.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, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: MECHANICAL PROBLEM. CONCLUSION: DEVICE FAILURE INDIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	WHEELCHAIR	WHEELCHAIR	IOR	EVEREST & JENNINGS, INC.	UM SELECT	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Required Intervention