ZIMMER TOURNIQUET 60-4000-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-02 for ZIMMER TOURNIQUET 60-4000-001 manufactured by Zimmer.

Event Text Entries

[21634198] A 61 year old female - scheduled for carpal tunnel release - the double cuff tourniquet was tested prior to surgery, and the cuff was placed on patient. The cuffs were inflated and the patients arm was ersanquinated and injected with 40cc of. 5% lidocaine. Arm became red, and physician was able to asperate venaus blood. At that point patient lost consciousness and was supported by the that anesthelogist. Patient had no seizure activity or cardiac ectopy. Surgery proceded under general anesthesia. Patient tolerated procedure well. Anesthesia felt that patient received bolus of lidocaine because tourniquet cuff did not maintain adequate pressure. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4484
MDR Report Key4484
Date Received1992-07-02
Date Added to Maude1993-05-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameZIMMER TOURNIQUET
Generic NamePOWER TOURNIQUET
Product CodeDRP
Date Received1992-07-02
Model Number60-4000-001
Lot NumberN/A
ID NumberDSU #1 AKH #31182
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key4204
ManufacturerZIMMER


Patients

Patient NumberTreatmentOutcomeDate
101. No Informationnvalid Deathata 1992-07-02

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