FDA Adverse Event Injury Summary report: N

WHIRLPOOL BATHING UNIT

MDR report key: 3703 · Received July 27, 1992

Report

Report Number
3703
Event Type
Injury
Date Received
July 27, 1992
Date of Event
January 19, 1992
Report Date
January 22, 1992
Manufacturer
CENTURY MANUFACTURING
Product Code
ILJ
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

THE INCIDENT OCCURRED AT 2:50 P.M. ON SUNDAY, JANUARY 19, 1992. TWO NURSE AIDES HAD JUST COMPLETED A TESIDENT'S BATH IN A CENTURY TUB AND WERE LOWERING THE RESIDENT IN THE BATH CHAIR TO THE SAF-KARY FRAME USING A LIFT WITH SAFETY LOCK PART #205010. THEY REPORTED THAT THE BATH CHAIR DISLODGED FROM THE LIFT WHEN THE CHAIR WAS ALMOST DOWN TO THE SAF-KARY FRAME. THE AIDES LOWERED THE CHAIR WITH THE RESIDENT IN IT TO THE FLOOR. THE RESIDENT SUSTAINED A BRUISE TO THE LEFT ELBOW AND THE RIGHT KNEE, AND COMPLAINED OF DISCOMFORT ON MOVEMENT TO THE RIGHT LEG.RESIDENT SENT TO HOSPITAL ON SUNDAY AFTERNOON, JANUARY 19, FOR EVALUATION. X-RAYS WERE NEGATIVE FOR ANY FRACTURE AND THE RESIDENT RETURNED TO THE FACILITY THE SAME DAY.THE CHARGE NURSE DETERMINED THAT THE LIFT SHOULD NOT BE USED UNTIL IT WAS EVALUATED BY THE DIRECTOR OF NURSING AND DIRECTOR OF GENERAL SERVICES. THIS EVALUATION WAS COMPLETED ON JANUARY 20, 1992.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-AUG-90. 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 WHIRLPOOL BATHING UNIT HYDRAULIC TUB LIFE ILJ CENTURY MANUFACTURING T601 N/

Patients

Seq Age Sex Outcome Treatment
1 89 YR Required Intervention