FDA.reportPublic FDA data

MAUDE MDR 4797

MDR report key
4797
Report number
4797
Event key
0
Event type
3
Date of event
1992-02-03
Date received
1992-07-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPERATING ROOM TABLEAMERICAN STERILIZER COMPANYFSE*N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-07-3101. O

Event Narratives#

D

Patient 1

AN OPERATING ROOM TABLE, MOVED DURING A SURGICAL PROCEDURE, DESPITE BEING LOCKED IN PLACE PRE-OPERATIVELY.L THE TABLE WAS RE-LOCKED, BUT CONTINUED TO MOVE WHEN LEANED UPONINVALID 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. 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.