MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON CL FETAL & MATERNAL PATCH

Model Number	989803196341
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.(b)(6).
Event or Problem Description
It was reported that the patient developed a tissue injury or skin tear from the fetal monitoring pod, so the pod was removed.The device was in clinical use, patient involvement was reported.
Event or Problem Description
It was reported the patient developed a tissue injury or skin tear from the fetal monitoring pod, so the pod was removed.No other clinical information or medical intervention was reported.
Additional Manufacturer Narrative
A good faith effort (gfe) was made to obtain additional information on the reported issue and in response it was indicated that there was no pictures of the injury were available.The area of injury was on the lower abdomen, approximately 1.1cm in size with superficial skin loss consisting of dry skin.The injury was in the shape of the hub of the pod.The patient's skin is being assessed daily but no intervention was required, and the injury was expected to heal completely.Based on this information, the reported trauma to the patient's skin does not meet the criteria for serious injury.The customer confirmed that the avalon cl fetal & maternal patch was not checked.The patch was removed by the midwife when the skin injury was observed and thrown away because it was disposable.The customer also confirmed that there was no fault observed in the device and the device was working as intended.The allegation was against the patch and not the device.The patch was not availablefrom customer so no evaluation could be done.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.

• Brand Name: AVALON CL FETAL & MATERNAL PATCH
• Common Device Name: AVALON CL FETAL & MATERNAL PATCH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19172479
• Report Number: 1218950-2024-00293
• Device Sequence Number: 18106859
• Product Code: FHM
• UDI-Device Identifier: 20884838059324
• UDI-Public: 20884838059324
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 989803196341
• Device Catalogue Number: 989803196341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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: Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 50 KG