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

Model Number 989803137631

Device Problem Positioning Problem (3009)

Patient Problem Head Injury (1879)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that the patient had head injury due to of the placement of the scalp electrode.

Manufacturer Narrative

H10: the customer disposed of the device therefore device evaluation data is not available.The customer was provided with information on how to avoid tip breakage and what to do if it were to occur.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.H3 other text : the customer discarded the device.

Event Description

The customer reported that the patient had head injury due to the placement of the scalp electrode.

• 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: 10802041
• MDR Text Key: 215075983
• Report Number: 1218950-2020-06709
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1