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 Problems Shelf Life Exceeded (1567); 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 ¿on baby¿s head, would not read anything.2 different cables used.¿ customer confirmed that after looking at the packaging the fetal scalp electrode expired on (b)(4) 2017.

• 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: 7538629
• MDR Text Key: 109070838
• Report Number: 2050001-2018-00106
• 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: consumer,health professional
• 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

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 7000AAO
• Device Lot Number: S49141-F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention