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

Model Number 989803137631

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Unable to confirm serial number a follow-up report will be submitted once the investigation is complete.

Event Description

It was reported to philips that the ¿metal part of the electrode detached from the device¿ during insertion.The metal part of the fetal electrode detached from the device during insertion, and was found under the skin of the patients head.The provider was unable to remove the electrode.

Manufacturer Narrative

H10: the metal part of the fetal electrode detached from the device during insertion, and was found under the skin of the patients head.The device was returned to philips where a service technician confirmed the customer issue.The returned device was 100% visually inspected and the needle was found to be broken from the white hub.Functionality test cannot be performed because the needle was broken.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: 10585670
• MDR Text Key: 208499091
• Report Number: 1218950-2020-05658
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: (01)20884838007431
• Combination Product (y/n): N
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Device Lot Number: 192761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 3