FDA Adverse Event Death Summary report: N

SAF-LIFT & SAF-KARY WHIRLPOOL BATHING SYSTEM

MDR report key: 23104 · Received June 5, 1995

Report

Report Number
23104
Event Type
Death
Date Received
June 5, 1995
Date of Event
December 14, 1994
Report Date
May 31, 1995
Manufacturer
ARJO MFG
Product Code
ILJ
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

AN 81-YR-OLD NURSING HOME RESIDENT WAS PLACED IN PARTIALLY FILLED WHIRLPOOL TUB BY NURSE AID AND LEFT UNATTENDED WHILE WATER CONTINUED TO FILL TUB. ANOTHER NURSE AIDE FOUND RESIDENT (AN UNDETERMINED AMOUNT OF TIME LATER) IN BOILING HOT WATER WITH SKIN SLOUGHING ALREADY OCCURRING. RESIDENT DIED SEVERAL DAYS LATER AS A DIRECT RESULT OF 1ST AND 2ND DEGREE BURNS AND COMPLICATIONS THEREFROM. SUBSEQUENT INVESTIGATION REVEALED AMONG OTHER THINGS, THAT THE THERMOSTATIC MIXING VALVE AND TEMPERATURE GAUGE AT THE NURSING HOME'S HOT WATER HEATER HAD CORRODED/CALCIFIED FROM YEARS OF NEGLECT AND RENDERED INOPERABLE; THEREBY ALLOWING SCALDING HOT WATER INTO RESIDENT'S TUB. ADDITIONALLY, THE TEMPERATURE GAUGE AND OTHER SAFETY DEVICES ON THE WHRILPOOL TUB FAILED, EITHER FROM MALFUNCTION OR NEGLECT OR A COMBINATION OF BOTH.DEVICE 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: UNKNOWN. 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: INADEQUATE QUALITY ASSURANCE, MATERIAL DEGRADATION/DETERIORATION, FAILURE TO SERVICE/MAINTAIN ACCORDING TO MANUFACTURER RECOMM, INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SAF-LIFT & SAF-KARY WHIRLPOOL BATHING SYSTEM ILJ ARJO MFG MCT10V

Patients

Seq Age Sex Outcome Treatment
1 81 YR Death