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

Model Number 989803137631

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter:phone not provided.A follow-up report will be submitted once the investigation is complete.The injury was superficial.Betadine was applied after removal of the metal piece and no permanent injury is expected.

Event Description

The customer reported that the fetal electrode was easily removed after a delivery.However , it was noticed that a sliver of the metal electrode was superficially stuck in the infant's head and had to be removed with a hemostat by one of the residents.

Manufacturer Narrative

H10: the material was not available for further evaluation as the product was discarded.Because of this, we are considering this to be a malfunction of unknown cause with insufficient.Information.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: FETAL SPIRAL ELECTRODE
• Type of Device: FETAL SPIRAL ELECTRODE, SINGLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9476280
• MDR Text Key: 171605122
• Report Number: 1218950-2019-09488
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• 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: 191062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA