FDA Adverse Event Malfunction Summary report: N

MASTER TERMINAL

MDR report key: 4108 · Received July 20, 1992

Report

Report Number
4108
Event Type
Malfunction
Date Received
July 20, 1992
Date of Event
January 27, 1992
Report Date
February 11, 1992
Manufacturer
HEWLETT PACKARD
Product Code
KXN
Product Problem
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MASTER TERMINAL CENTRAL DISPLAY MONITOR FOR FETAL MONITORING SYSTEM KXN HEWLETT PACKARD 2392A N/A

Patients

Seq Age Sex Outcome Treatment
1 Other