HEWLETT-PACKARD 68532B 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 1993-02-15 for HEWLETT-PACKARD 68532B N/A manufactured by Hewlett-packard.

Event Text Entries

[1033] During a thunderstorm, the lights became unusually bright, then went off approximately 5 seconds. When they came back on, the monitor was smoking. It was immediately disconnected from the patient and then the wall. This patient is a trauma patient with burns on 63% of her body. The monitor was being used for heart pressure, blood pressure and ekg readings. A new monitor was immediately put on the patient and she seemingly suffered no ill effects. No other monitors were affected on the burn unit when the power was restored. The bio-med department has found a melted component in the monitor, but has not yet determined the cause. Device 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-apr-92. 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, performance tests performed, visual examination. Results of evaluation: electrical problem, none or unknown, integrated circuit board. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3625
MDR Report Key3625
Date Received1993-02-15
Date of Report1992-09-15
Date of Event1992-09-09
Date Facility Aware1992-09-09
Report Date1992-09-15
Date Reported to FDA1992-09-15
Date Reported to Mfgr1992-09-15
Date Added to Maude1993-04-28
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 NameHEWLETT-PACKARD
Generic NameMONITOR
Product CodeDRQ
Date Received1993-02-15
Model Number68532B
Catalog NumberN/A
Lot NumberN/A
ID NumberHOSPITAL NO. 6902
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Age01-MAR-86
Implant FlagN
Device Sequence No1
Device Event Key3371
ManufacturerHEWLETT-PACKARD


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-02-15

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