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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

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VYAIRE MEDICAL VITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR Back to Search Results
Catalog Number 7000AAO
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative

Vyaire complaint (b)(4). Any additional information provided by the customer will be included in a follow-up report. Due diligence is ongoing. At this time, vyaire is pursuing additional information and sample availability for evaluation.

 
Event Description

A customer contacted vyaire medical to report that two wires (pink & blue) seemed to be twisted in the wrong direction. When the end user was attempting to pull the wires apart to disengage from the (unborn) baby's head, instead of the small corkscrew wire that is at the end of the electrode unscrewing, it was screwing deeper into the unborn baby's head. This is the first time the end user customer experienced the issue. There was no indication of patient harm or medical intervention during initial contact.

 
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Brand NameVITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS
Type of DeviceELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
Manufacturer (Section G)
PRECISION CONCEPTS COSTA RICA SA
saret free zone building d3
p.o. box 74-4002
alajuela,
CS
Manufacturer Contact
stanley tan
22745 savi ranch pkwy
yorba linda, CA 92887
7149193324
MDR Report Key8184893
MDR Text Key131065602
Report Number3003678543-2018-00001
Device Sequence Number1
Product Code HGP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK792669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7000AAO
Device LOT NumberS07181-F, S35171-F
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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