FDA Adverse Event Malfunction Summary report: N

G U SURGICAL TABLE

MDR report key: 5673 · Received July 13, 1993

Report

Report Number
5673
Event Type
Malfunction
Date Received
July 13, 1993
Date of Event
June 24, 1993
Report Date
June 30, 1993
Manufacturer
LEIBEL FLOROSHIEM COMPANY
Product Code
FWW
Product Problem
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

THE PROBLEM WAS DESCRIBED AS THE ELECTRIC BED HAND CONTROL BECAME WET WITH BLOOD DUE TO THE NASAL BLEEDER. THE HAND CONTROL SHOSRTED OUT, CAUSING THE BED TO ELEVATE TO THE HIGHEST LEVEL AND UP INTO TRENDELENBURG. THE BED WAS UNPLUGGED TO PREVENT DAMAGE TO THE PATIENT'S POSITION. BIO-MEDICAL WAS CALLED IN FOR REPAIR ON THE HAND CONTROL. THE REMAINDER OF THE SURGGERY WAS PERFORMED WITH THE PATIENT IN THE REVERSE TRENDELENBURG POSITION. THE TABLE HAS BEEN REMOVED FROM USE IN SURGERY. THERE IS NO APPARENT INJURY TO THE PATIENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS 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. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 G U SURGICAL TABLE SURGICAL TABLE FWW LEIBEL FLOROSHIEM COMPANY NONE NONE

Patients

Seq Age Sex Outcome Treatment
1 75 YR Other