MONITOR DEFIBRILLATOR GPN HP 43110A N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-13 for MONITOR DEFIBRILLATOR GPN HP 43110A N/A manufactured by Hewlett Packard.

Event Text Entries

[18447017] On may 26, 1993 at 9:45 pm the patient involved was exhibiting changes in hger telemetry monitor pattern. She had been in supraventricular rythum of approx. 150 bmp. Her rate slowed to 91 and then to 69 with widening of the qrs complex. The nurses were with her and she became unresponsive. Her widening of the qrs complex was considered to have progressed to emd (electomechanical dysfunction) which is a lethal rythum because the electrical impulse does not stimulate and cardiac muscle contraction. The defibrillator had been checked earlier in the same shift and functioned properly. It was charged and discharged into the patient. At this time the defibrillator went blank and would not function at all. Ast this time other alternative measures were taken and another defibrillator was obtained. The patient was in critical condition prior to code and did expire at 10:30 p. M. Engineering was called to evaluate the problem with the defibrillator. It was determined that this event could not have been predicted. The internal had leaked and was destroyed with the discharge the patient received. The battery was replaced and the defibrillator is now back in usedevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-feb-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, performance tests performed. Results of evaluation: battery/pack. Conclusion: device failure occurred and was related to event, other. Certainty of device as cause of or contributor to event: no. Corrective actions: device repaired and put back in service, other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5676
MDR Report Key5676
Date Received1993-07-13
Date of Report1993-06-18
Date of Event1993-05-26
Date Facility Aware1993-05-26
Report Date1993-06-18
Date Reported to Mfgr1993-06-18
Date Added to Maude1993-07-20
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 NameMONITOR DEFIBRILLATOR GPN
Generic NameDEFIBRILLATOR
Product CodeDRK
Date Received1993-07-13
Model NumberHP 43110A
Catalog NumberN/A
Lot NumberN/A
ID NumberMD21
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Age01-JUN-87
Implant FlagN
Device Sequence No1
Device Event Key5375
ManufacturerHEWLETT PACKARD


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1993-07-13

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