MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM50 FETAL MONITOR

Model Number	865071
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer requested documenting concerning (b)(4) or service history of a fco being applied to the device in question.A philips product support engineer (pse) provided another fco (b)(4) in which the serial number was listed on the can application layer (cal).A philips regional service manager (rsm) followed up with customer, and told them philips will continue to research the request and that the initial fco was for an addendum to the instruction for use ifu.At the time of the follow-up, the customer indicated they wanted to be transparent that the reason why they are asking for the documentation was due to pending litigation.It is unknown if the device was in clinical use.The report was marked as patient harm.The nature of the harm was not provided at the time of this report.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
H3 other text : no alleged product malfunction.
Event or Problem Description
After further investigation, this complaint was deemed not a reportable event with philips.The customer requested documentation concerning fco86201075a or service history of a fco being applied to the device in question.A philips product support engineer (pse) provided another fco 86201218a in which the serial number was listed on the can application layer (cal).A philips regional service manager (rsm) followed up with customer, and told them philips will continue to research the request and that the initial fco was for an addendum to the instruction for use ifu.At the time of the follow-up investigation, the customer indicated they wanted to be transparent that the reason why they are asking for the documentation was due to pending litigation.The customer confirmed that there was no patient harm associated with this request.The customer was requesting the service history regarding the involved device.

• Brand Name: AVALON FM50 FETAL MONITOR
• Common Device Name: AVALON FM50 FETAL MONITOR
• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15614909
• Report Number: 9610816-2022-00523
• Device Sequence Number: 8086897
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: 00884838000438
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,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
• Operator of Device: Health Professional
• Device Model Number: 865071
• Device Catalogue Number: 865071
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2008
• 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: Other
• Patient Sex: Unknown