N/A 78341A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-24 for N/A 78341A manufactured by Hewlett Packard.

Event Text Entries

[791] Patient was attached to monitor. Nurse observed the baby to be cyanotic with no respirations. Heart rate by monitor was 100. No alarms sounded. Baby was sucessufully resusciated. The test/cal button on the monitor was found to be in a depressed position which created the test function of 100 beats per minute to occur on monitor, even though baby's heart rate was below that. The test/cal button was lodged in depressed position with a piece of paperdevice 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-apr-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, computer software performance tests conducted, performance tests performed, visual examination. Results of evaluation: design - human factors, modification of device - by user, none or unknown. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: inserviced by biomedical engineering dept. Staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1180
• MDR Report Key: 1180
• Date Received: 1992-08-24
• Date of Report: 1992-07-30
• Date of Event: 1992-07-24
• Date Facility Aware: 1992-07-24
• Report Date: 1992-07-30
• Date Reported to FDA: 1992-07-30
• Date Reported to Mfgr: 1992-07-30
• Date Added to Maude: 1992-09-02
• 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: N/A
• Generic Name: N/A
• Product Code: HEL
• Date Received: 1992-08-24
• Model Number: 78341A
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: 2993
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-80
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1128
• Manufacturer: HEWLETT PACKARD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-08-24