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

Model Number	453564667151
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
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 a patient on the table having a stemi (st-segment elevation myocardial infarction) and there is no ecg.Customer stated that all other vitals are fine.Staff reportedly is using a defibrillator to monitor the patient's ecg.The device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Philips technical support (ts) was able to remotely assist the customer with the reported problem.According to case notes, the customer was advised to perform a full power drain of the system.Once this was completed, the reported issue was resolved.A search found no further related calls.The absence of further calls supports that the reported problem was resolved.The device remains in use at the customer's facility.No further action or investigation is warranted based on the available information at the time of complaint closure.
Event or Problem Description
The customer reported a patient on the table having a stemi (st-segment elevation myocardial infarction) and there is no ecg.Customer stated that all other vitals are fine.Staff reportedly is using a defibrillator to monitor the patient's ecg.The device was in use at time of event; there was no adverse event reported.Subsequent information received regarding the incident indicated that, the patient was brought into the cath lab during an active stemi.There was no allegation that the device contributed in any way to the patient¿s heart attack as the patient was in this condition when they attempted to use the device.The customer did not report that the alleged device malfunction delayed treatment of the patient or could have delayed treatment, nor was there any patient harm or injury reported by the customer as a result of this incident.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15350623
• Report Number: 1051786-2022-00042
• Device Sequence Number: 6002734
• Product Code: MWI
• UDI-Device Identifier: 00884838083820
• UDI-Public: 00884838083820
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564667151
• Device Catalogue Number: 453564667151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2019
• 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