MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON PATIENT MODULE

Model Number	989803144241
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported fetal monitoring was difficult and there was a loss of signal during epidural insertion, requiring placement of a fetal scalp electrode.Once in place, the monitor generated a coincidence alarm for 20 minutes between the fetal and maternal heart rates.Following the vaginal birth, the baby was brought to the nicu but could not be resuscitated and subsequently passing away.There were no complications during delivery and autopsy of the baby was pending.The customer did not believe there should have been a coincidence when using a fetal scalp electrode.The electrode was discarded, and the monitors sequestered.
Additional Manufacturer Narrative
Multiple attempts were made to obtain additional information regarding the event, with no response from the customer.No further information was provided.Based on the information available, the cause of the reported problem was not able to be established.The reported problem was not confirmed multiple attempts were made to obtain the device context of use, evaluation, repair, and operational status with no response from the customer.No further information was provided; therefore, the device operation was not able to be confirmed.

• Brand Name: AVALON PATIENT MODULE
• Common Device Name: AVALON PATIENT MODULE
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 19561343
• Report Number: 9610816-2024-00352
• Device Sequence Number: 20753297
• Product Code: HGM
• UDI-Device Identifier: 00884838012141
• UDI-Public: (01)00884838012141
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 989803144241
• Device Catalogue Number: 989803144241
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown