TOURNIQUET SYSTEMS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-08 for TOURNIQUET SYSTEMS manufactured by Aspen Labs.

Event Text Entries

[1496] On 7/11/92 a bier block including tourniquet was administered to a 19 year old male who was in surgery for an open reduction internal fixation of the right 5th metacarpal fracture. During the administration of the bier block, the tourniquet failed to maintain pressure. The staff through the pressure cuff itself had leaked and thereby replaced the cuff. After new cuff was in place, the tourniquet with another unit while using the second presure cuff. After this second tourniquet was connected, the pressure was maintained and the surgery continued withput further incidence. When the original tourniquet failed, the patient developed lidocainae toxicity as evidenced by light headedness and early seizure activity. The patient was given pentothal and a muscle relaxant to stop the seizures. The patient was alo intubated in order to maintain oxygen and to protect the airwaydevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-aug-91. 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, electrical tests performed, mechanical tests performed, performance tests performed. Results of evaluation: electrical problem, power cord. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2691
MDR Report Key2691
Date Received1993-01-08
Date of Report1992-07-29
Date of Event1992-07-11
Date Facility Aware1992-07-17
Report Date1992-07-29
Date Reported to FDA1992-07-29
Date Reported to Mfgr1992-07-29
Date Added to Maude1993-03-23
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

Generic NameTOURNIQUET SYSTEMS
Product CodeDRP
Date Received1993-01-08
ID NumberPM# 15647
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key2515
ManufacturerASPEN LABS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-01-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.