MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO MEDICAL EQUIPMENT

Model Number	860335
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
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
Philips received a complaint on the xper flex cardio 2010 rev-c-exchange indicating there was no audio.The device was not in use on a patient at the time of event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips technical support engineer (tse) went onsite to evaluate the device in question.The tc provided the customer with an exchange device to resolve the issue.The tc sent the original device for bench repair for further evaluation.At the bench, it was confirmed the device "does not" have sound coming from the speaker.Side note: the unit itself was pretty beat up and corroded, it also has the old revision speaker installed in it.After the device was exchanged with a new one, the customer's issues were resolved.The original device was evaluated at bench repair, and it was confirmed it had an old revision speaker with no sound.No further investigation or action is warranted at this time.

• Brand Name: XPER FLEX CARDIO MEDICAL EQUIPMENT
• Common Device Name: XPER FLEX CARDIO MEDICAL EQUIPMENT
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: deborah currlin ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 20419306
• Report Number: 1051786-2024-00013
• Device Sequence Number: 8613058
• Product Code: MWI
• UDI-Device Identifier: 00884838084926
• UDI-Public: (01)00884838084926
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 860335
• Device Catalogue Number: 860335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• 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