FDA Adverse Event Injury Summary report: N

RJO CENTURY

MDR report key: 2043 · Received January 6, 1993

Report

Report Number
2043
Event Type
Injury
Date Received
January 6, 1993
Date of Event
December 14, 1992
Report Date
December 15, 1992
Manufacturer
CENTURY
Product Code
FNG
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

ON DECEMBER 14, 1992, A RESIDENT OF THIS NURSING HOME HAD BEEN STRAPPED INTO THE LIFT CHAIR FOR THE WHIRLPOOL TUB. AS HE WAS BEING RAISED TO GO INTO THE TUB, THE LIFT CHAIR AND HYDRAULIC TOWER FELL WITH THE RESIDENT STILL IN THE CHAIR. THE BASE OF THE UNIT HAD BROKEN. THE UNDERSIDE OF THE BASE HAD CORRODED AND LEFT A VERY THIN SHELL.THE RESIDENT SUSTAINED ABRASIONS TO BOTH KNEES AND A NON-DISPLACED FRACTURE OF THE LEFT TIBIAL PLATEAUDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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 TEMPORARILY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RJO CENTURY WHIRLPOOL TUB WITH HYDRULIC LIFT FNG CENTURY H7-1

Patients

Seq Age Sex Outcome Treatment
1 76 YR Required Intervention