MASTER TERMINAL 2392A 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 1992-07-20 for MASTER TERMINAL 2392A N/A manufactured by Hewlett Packard.

Event Text Entries

[2840] Chart placed on keyboard. Entire system locked up. Hewlett packard obms system also in used at the same time. Problem affectefd central display monitor only. Bedside monitors including ability to produce fetal monitor strips not affected. Nursing staff notified that patients could no be monitored at the central station, but could be monitored directly at the bedside. No compromise in any patient's care. Hewlett packard technician gave instructions via phone for the nursing staff to get the system up and running again. Approximate down time: 50 minutesdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved: 6. Device serviced in accordance with service schedule. Date last serviced: 01-jan-92. Service provided by: factory trained/authorized/owned service organization. Service records available. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: incorrect technique/procedure. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4108
• MDR Report Key: 4108
• Date Received: 1992-07-20
• Date of Report: 1992-02-11
• Date of Event: 1992-01-27
• Date Facility Aware: 1992-01-27
• Report Date: 1992-02-11
• Date Reported to Mfgr: 1992-02-11
• 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: MASTER TERMINAL
• Generic Name: CENTRAL DISPLAY MONITOR FOR FETAL MONITORING SYSTEM
• Product Code: KXN
• Date Received: 1992-07-20
• Model Number: 2392A
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3841
• Manufacturer: HEWLETT PACKARD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-20