MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FETAL SPIRAL ELECTRODE

Model Number	989803137631
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported to philips that the fetal heart rate monitor sensor was so tightly attached to the baby's head that it took 3 people to remove it.The device was being used on a patient there was a larger-than-usual leaking hole left in the skin.A wet spot that later developed on the site, which was squeezed empty and cleaned when the baby was (b)(6) at a pediatric examination.
Additional Manufacturer Narrative
The device was disposed off by the customer and therefore device evaluation data is not available.A good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but there is no additional information available.
Event or Problem Description
It was reported to philips that the fetal heart rate monitor sensor was so tightly attached to the baby's head that it took 3 people to remove it.The device was being used on a patient there was a larger-than-usual leaking hole left in the skin.A wet spot that later developed on the site, which was squeezed empty and cleaned when the baby was 5 days old at a pediatric examination.

• Brand Name: FETAL SPIRAL ELECTRODE
• Common Device Name: FETAL SPIRAL ELECTRODE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13654692
• Report Number: 1218950-2022-00180
• Device Sequence Number: 5780018
• Product Code: HGP
• UDI-Device Identifier: 20884838007431
• UDI-Public: 20884838007431
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K030691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Model Number: 989803137631
• Device Catalogue Number: 989803137631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 1 DA
• Patient Sex: Unknown