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

Model Number 989803196341

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2024

Event Type  Injury  

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 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.

• Brand Name: AVALON CL FETAL & MATERNAL PATCH
• Type of Device: 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19172479
• MDR Text Key: 340918685
• Report Number: 1218950-2024-00293
• Device Sequence Number: 1
• Product Code: FHM
• UDI-Device Identifier: 20884838059324
• UDI-Public: 20884838059324
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: 989803196341
• Device Catalogue Number: 989803196341
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/24/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other