FDA.reportPublic FDA data

MAUDE MDR 1223

MDR report key
1223
Report number
1223
Event key
0
Event type
3
Date of event
1992-08-05
Date received
1992-08-27
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
13080 RC TABLEOR TABLEAMSCOFWW3080 RCN/ANY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-08-2701. O

Event Narratives#

D

Patient 1

FOLLOWING LAST CASE OF DAY. NURSING STAFF NOTED AMBER COLOR LIQUID ON THE FLOOR BENEATH THE OR TABLE. AMSCO SERVICE REPRESENTATIVE NOTIFIED. SALES REP. REPORTED HYDRAULIC HOSE SUPPORT POST HOLE TAPPED THROUGH TABLE BASE,- ALLOWING ANY OIL IN BASE TO RUN OUT ONTO FLOORDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-92. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. 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, OTHER. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.