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 Number: 3625
• MDR Report Key: 3625
• Date Received: 1993-02-15
• Date of Report: 1992-09-15
• Date of Event: 1992-09-09
• Date Facility Aware: 1992-09-09
• Report Date: 1992-09-15
• Date Reported to FDA: 1992-09-15
• Date Reported to Mfgr: 1992-09-15
• Date Added to Maude: 1993-04-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEWLETT-PACKARD
• Generic Name: MONITOR
• Product Code: DRQ
• Date Received: 1993-02-15
• Model Number: 68532B
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: HOSPITAL NO. 6902
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3371
• Manufacturer: HEWLETT-PACKARD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-02-15