MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC COROMETRICS QWIK CONNECT PLUS SPIRAL ELECTRODE; SYSTEM, MONITORING, PERINATAL

Catalog Number 7000AAO

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 05/02/2015

Event Type  malfunction  

Event Description

Female gravida 1 para 0 currently 40 weeks + 5 days gestation age presented for prodromal labor during which physician attempted to place 2 fast spin echo; neither would pick up the fetal heart rate correctly.Monitor parts were changed twice with each placement.A 3rd sfast spin echo placed and correctly working.

• Brand Name: COROMETRICS QWIK CONNECT PLUS SPIRAL ELECTRODE
• Type of Device: SYSTEM, MONITORING, PERINATAL
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC; 8200 west tower ave.; milwaukee WI 53223
• MDR Report Key: 4767819
• MDR Text Key: 18289182
• Report Number: 4767819
• Device Sequence Number: 2
• Product Code: HGM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/08/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 7000AAO
• Device Lot Number: S25141-F
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 20 YR
• Patient Weight: 75