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

Model Number	453564621791
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
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 it looks like the sweep speed changes on the monitor.The device was in use at time of event, there was no adverse event reported.
Event or Problem Description
The customer reported that it looks like the sweep speed changes on the monitor.The device was in use at time of event, there was no adverse event reported.Fse onsite called to report per wo-06638619 (8/26/2022).Report is that flex cardio software was mis-matched on stations where the random sweep speeds would occur.Once the flex cardio software was made the same on all stations, the issue reportedly went away.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.- 05oct2022 / jr.The customer reported that it looks like the sweep speed changes on the monitor.There was no reported patient impact / injury.A clinical assessment (ca) was initiated(b)(4).Capa pr 387687 and fco fco86400041 were also initiated.Any additional investigation or action taken will be documented in the respective capa.No additional action was deemed warranted at this time.
Event or Problem Description
The customer reported that it looks like the sweep speed changes on the monitor.The device was not in use at the time of the reported event.There was no reported patient impact / injury.A philips field service engineer (fse) went onsite and upon evaluating the device, determined the reported failure was caused by a software mis-match.The fse reloaded the software to resolve the sweep speed change issue.The device remains at the customer site.

• 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: 15375439
• Report Number: 1051786-2022-00043
• Device Sequence Number: 14868164
• Product Code: MWI
• UDI-Device Identifier: 00884838084926
• UDI-Public: 00884838084926
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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
• Device Model Number: 453564621791
• Device Catalogue Number: 453564621791
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 10/21/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/07/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2018
• 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