UNKNOWN 88050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-10 for UNKNOWN 88050 manufactured by Hewlett Packard.

Event Text Entries

[17249291] During the cath procedure it was noted that hp pressures and cuff pressures were not correlating. Hp pressures were 30 mm hg higher than expected. Patient was treated for severe hypertension. Patient responded with vagal reaction. Pressure module tested by in-house biomedical engineering staff. 30 mm hg inaccuracy wads re-simulated. Hp service notified. Module repaired by hp service. All other equipment used had no effect on pressure inaccuracydevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-91. Service provided by: factory trained/authorized/owned service organization. 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: electrical problem - open circuit. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4062
• MDR Report Key: 4062
• Date Received: 1992-08-10
• Date of Report: 1992-02-26
• Date of Event: 1992-02-13
• Date Facility Aware: 1992-02-13
• Report Date: 1992-02-26
• Date Reported to Mfgr: 1992-02-13
• Date Added to Maude: 1993-05-13
• 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: UNKNOWN
• Generic Name: AMPLIFIER, PRESSURE
• Product Code: FES
• Date Received: 1992-08-10
• Model Number: 88050
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-OCT-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3795
• Manufacturer: HEWLETT PACKARD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-10