MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION PATIENT MONITOR (MR400)

Model Number	866185
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the device shows a value above the expected value for spo2.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
A philips field service engineer (fse) went onsite to evaluate the device in question.The fse confirmed there was no actual delay or false low reading, and the waveform was ok.The fse reported there was an inoperative message present that read, "inoperative sensor".The fse observed the sensor was being worn on the big toe and that the adapter would be slightly raised compared to a new adapter (not worn) which could be the cause of the reading errors.The infrared beam emitter and receiver may no longer be aligned when used in this manner.The customer also reported the sensor was attached to the big toe when the event occurred.The fse recommended the adapter next time be worn on the fingers (hand).The customer was provided with an extra device for back up.The key market's followed-up response confirmed the spo2 adapter was not defective.The clip was connected to the patient's big toe, which caused the reading failures.After the nurse connected the adapter to the finger, the readings were correct.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be user error.Based on the information provided in the case and by key market, it was confirmed there was no issue with the device.The clip was connected to the patient's big toe, which caused the reading failures.After the nurse connected the adapter to the finger, the readings were correct.The device remains at the customer site.No further investigation or action is warranted at this time.
Additional Manufacturer Narrative
This supplemental report is submitted with reference to manufacturer's report number 1051786-2023-00010.The serial number of the device previously reported is incorrect.The actual serial number of the device is currently unknown.If additional information is received, the case will be reopened.

• Brand Name: EXPRESSION PATIENT MONITOR (MR400)
• Common Device Name: EXPRESSION PATIENT MONITOR (MR400)
• 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 ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 17684150
• Report Number: 1051786-2023-00010
• Device Sequence Number: 6246402
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: 00884838039131
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K15230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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
• Operator of Device: Health Professional
• Device Model Number: 866185
• Device Catalogue Number: 866185
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 08/11/2023; 08/11/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/25/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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