MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

Model Number	453564621791
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that artifacts are appearing in ecg and audio alarm is not coming.
Event or Problem Description
The customer reported that artifacts are appearing in ecg and audio alarm is not coming.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.A philips field service engineer (fse) went to the customer site.The fse evaluated the device and determined that the audio error was not present at the time of inspection, and that the audio volume was very low.The fse reseated the device speakers and confirmed that the device audio is now functioning as expected.No further investigation or action is warranted at this time.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• 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: jeanne ahearn ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 15578090
• Report Number: 1051786-2022-00050
• Device Sequence Number: 12604517
• Product Code: MWI
• UDI-Device Identifier: 00884838084926
• UDI-Public: 00884838084926
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564621791
• Device Catalogue Number: 453564621791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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
• Patient Sex: Unknown