CLINICOMP CIS AND FMRD SYSTEM NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-04 for CLINICOMP CIS AND FMRD SYSTEM NA manufactured by Clinicomp Intl..

Event Text Entries

[20192252] Subjects: fetal monitor remote display (fmrd) screen freezing. 1. In mar 1998 facility noticed that pc screens started to freeze. These were isolated incidents and the only way to unlock the screen was to reboot. Reported each time to clinicomp. It was felt that it was a problem with the emulation. 2. Shortly after that, the "ncd" screens began to lock up. Again isolated incidents, facility would call clincomp, who could not see an error and they stated they had reported it to software. The incidents have increased sometimes being as much as 4-5 times a week. The only way to resolve was to reboot. This happened in notes application as well as the pt select screen, several times when attempting to store. It has happened on pc's and "ncd's" in all locations of the hosp. 3. On 1 may 1998 facility had an episode where the fetal monitor remote display screen locked in a pt rm. Clinicomp was unable to "ping" the monitor. Facility checked the connections and the network. Once facility rebooted, it worked again. 7 may 1998 facility had another incident of fetal monitor remote display locking up. This presents a problem if a pt is being monitored in that rm. 4. Clinicomp has been unable to locate a software application abnormality. "fmrg's" are fda devices which are necessary to monitor a pt in labor. "my concern is if the screen freezes while caring for an active labor pt, potentially harmful info could be missed, and a detrimental outcome could occur. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002273
MDR Report Key173339
Date Received1998-06-04
Date of Report1998-05-13
Date Added to Maude1998-06-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCLINICOMP CIS AND FMRD SYSTEM
Generic NameFETAL MONITOR REMOTE DISPLAY
Product CodeHEL
Date Received1998-06-04
Model NumberNI
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key168537
ManufacturerCLINICOMP INTL.
Manufacturer Address9655 TOWNE CENTER DR. SAN DIEGO CA 92121 US


Patients

Patient NumberTreatmentOutcomeDate
10 1998-06-04

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