MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS MR PATIENT CARE PORTAL 5000

Model Number	MR PATIENT CARE PORTAL 5000
Medical Device Problem Codes	No Audible Alarm (1019); Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.Reporting institution phone#: (b)(6).
Event or Problem Description
The customer reported the device sometimes does not issue any sounds, which can present a risk for the patients.It is unknown if the device was in clinical use at the time the issue was discovered.  there was no adverse event or patient harm reported.
Additional Manufacturer Narrative
The customer reported the device sometimes does not issue any sounds, which can present a risk for the patients it is unknown if the device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.After turning the unit off and on repeatedly, the unit's audio was restored.This was a temporary fix; therefore, shown to be unreliable, as the unit sometimes remained in the error state afterwards.Results confirm the issue to be faulty circuit.The device remains at the customer site.
Event or Problem Description
The customer reported the device sometimes does not issue any sounds, which can present a risk for the patients it is unknown if the device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.After turning the unit off and on repeatedly, the unit's audio was restored.This was a temporary fix; therefore, shown to be unreliable, as the unit sometimes remained in the error state afterwards.Results confirm the issue to be faulty circuit.The device remains at the customer site.

• Brand Name: MR PATIENT CARE PORTAL 5000
• Common Device Name: MR PATIENT CARE PORTAL 5000
• 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: hisham alzayat ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 16195070
• Report Number: 1051786-2023-00001
• Device Sequence Number: 5971487
• Product Code: MWI
• UDI-Device Identifier: 00884838091948
• UDI-Public: 00884838091948
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: 5212227
• 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

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: MR PATIENT CARE PORTAL 5000
• Device Catalogue Number: 866162
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/01/2023
• Date Device Manufactured: 12/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown