MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE; FETAL SPIRAL ELECTRODE, SINGLE

Model Number 989803137631

Device Problem Separation Failure (2547)

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

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Serial number unknown.A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that the fetal spiral electrode would not unscrew correctly from the baby's head while in the womb.

Manufacturer Narrative

An evaluation could not be performed as the material was discarded.This event will considered as a malfunction of unknown cause with insufficient information.

Event Description

The customer reported fetal spiral would not come out of baby head when unscrewing in womb.The tip did not break but the doctor had to cut the cable because it would not unscrew correctly.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE, SINGLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8836774
• MDR Text Key: 152502816
• Report Number: 1218950-2019-05543
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: (01)20884838007431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA