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Adverse Event Report

CENTURY WHIRLPOOL TUB HYDRAULIC LIFT   back to search results
Model Number C22.2N012.5 LR23570-4-5
Patient Outcome  Other;
Event Description

On march 27, 1992 a certified nursing assistant was removing a patient from the whirlpool tub and the hydraulic lift base cracked causing the base to uproot from the floor. The resident in the lift chair fell from the highest point to the ground. The resident was not injured. The nursing assistant operating the lift received bruises to his arm. Reviewing the situation the maintance department determined the pedestal base had deteriorated from the underside (not visible during routine preventive maintenance) to a point that the hydraulic cylinder completely broke off the base invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.

 
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Type of DeviceHYDRAULIC LIFT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CENTURY WHIRLPOOL TUB
Manufacturer (Section D)
CENTURY WHIRLPOOL TUB
Device Event Key413
MDR Report Key419
Event Key356
Report Number419
Device Sequence Number1
Product CodeFNG
Report Source User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/03/1992
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/1992
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device MODEL NumberC22.2N012.5 LR23570-4-5
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/03/1992
Event Location Invalid Data
Is the Device an Implant? No Answer Provided

Database last updated on January 30, 2009

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