FDA Adverse Event Injury Summary report: N

CENTURY

MDR report key: 1728 · Received October 22, 1992

Report

Report Number: 1728
Event Type: Injury
Date Received: October 22, 1992
Date of Event: September 28, 1992
Report Date: October 8, 1992
Manufacturer: ARJO-CENTURY, INC.
Product Code: FNG
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

HYDRAULIC CENTURY-TUB LIFT BASE BROKE FROM THE FLOOR DUE TO CORROSION WITH A PATIENT OCCUPYING THE LIFT SEAT. PATIENT FELL WITH THE DEVICE AND FRACTURED FOUR (4) RIBSDEVICE 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-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS NOT AVAILABLE.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, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CENTURY	N/A	FNG	ARJO-CENTURY, INC.	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention