MAUDE Adverse Event Report: PRECISION CONCEPTS COSTA RICA SA ELECTRODES, FETAL SCALP (FSE), 50/CASE; ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Catalog Number 7000AAO

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

Vyaire has reached out to customer to provide the complaint device for further investigation.At this time we are currently waiting for the sample.If the customer provides the sample for further investigation or additional information is obtained, vyaire will provided a follow up emdr.

Event Description

Customer reported ¿two rns at bedside attempting to place scalp lead.First scalp lead did not read heart rate bounced around on monitor.We tried troubleshooting and replaced the cords, jiggled them around, etc.With no luck.Fetal scalp electrode (fse) was removed.

• Brand Name: ELECTRODES, FETAL SCALP (FSE), 50/CASE
• Type of Device: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): PRECISION CONCEPTS COSTA RICA SA; saret industrial park building; alajuela; rio segundo 74-4002 ; CS
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA SA; saret industrial park building; alajuela; rio segundo 74-4002 ; CS
• Manufacturer Contact: avery foster ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7538557
• MDR Text Key: 109092648
• Report Number: 2050001-2018-00105
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K792669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7000AAO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 05/23/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention