GENESIS MONITOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-17 for GENESIS MONITOR manufactured by Carelink.

Event Text Entries

[19252] Patient monitored uterine activity on 9/25/94 at 1555. Device would not transmit data over the phone lines despite repeated trouble shooting attempts, monitor was replaced with another monitor on 9/25/94. Patient monitored uterine activity using new device and data would not transmit over the phone lines despite repeated trouble shooting attempts, patient was not symptomatic for preterm labor at this time. At 2009 on 9/25/94, patient was instructed to call clinic with any s/s of preterm labor or if she felt any uterine contractions. This clinic was planning to call the patient's insurance company in the morning to discuss using a different type of monitor since there was transmission problems with the monitor and the patient's phone. On 9/26/94 at 0343, the patient's husband called stating that his wife was contracting. Appropriate clinical actions were taken. At 0424, patient's husband called again stating his wife had 2 hard contractions. There was no uterine activity data available since the 2 monitors wound not transmit. Subsequently, the patient went to the hospital at 0500, had cervical dilation to 3-4cms, and was stablized on iv mag sulfate. Patient was 28 + 1 weeks gestation at the time of the incident. Patient was also on the sp infusion pump for terbutaline therapy. No malfunction or user error occured with this device. Device 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:. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number25622
MDR Report Key25622
Date Received1995-01-17
Date of Report1994-10-04
Date of Event1994-09-25
Date Facility Aware1994-09-25
Report Date1994-10-04
Date Reported to Mfgr1994-10-04
Date Added to Maude1995-09-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameGENESIS MONITOR
Generic NameNA
Product CodeHFM
Date Received1995-01-17
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorOTHER CAREGIVERS
Device Availability*
Implant FlagN
Device Sequence No1
Device Event Key26198
ManufacturerCARELINK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1995-01-17

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