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

Model Number	866185
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Minimal information about the patient was provided.It was reported that the patient had a history of being overmedicated and being unarousable.It is unknown how this information relates to this incident.Multiple requests were made for additional information related to both the patient and the event itself, but no additional information was provided.Philips clinical product specialist (cps) visited the customer site per the customer¿s request.The cps found several items that were contributing factors to the device experiencing spo2 interference, all related to proper use, care and maintenance of the spo2 accessories.According to the cps, the spo2 cable itself was only halfway seated into the base of the wireless module.There are two screws used to affix the spo2 cable securely to the wireless module - one screw was found to not be attached causing the cable to wobble in and out of the actual connection since it was not secure.The cps removed the spo2 cable and inspected it further.Partial darkness was found in the light-emitting end of the cable, indicating that some of the fiber optics are damaged.Finally, it was found that 3 clips of the adult reusable spo2 clip were broken.As a result of this, the spo2 cable failed to remain in the clip.All of these findings contributed to the spo2 interference issues with the device.The above-referenced findings were reviewed with the customer.After the spo2 cable was completely attached to the base of the wireless module, no further movement of the cable was detected.Additionally, the customer indicated that they would be ordering a new spo2 cable.The cps also replaced the adult spo2 clip.The investigation did not confirm that a malfunction of the device occurred.
Event or Problem Description
The customer reported that they had concerns about spo2 not functioning properly during a patient examination.According to the customer, the spo2 readings were in the 80's when monitoring of the patient began before the examination.Interference was reportedly noted on the spo2 reading and it was reported that the technologists were unsure if the readings were reliable.The technologists continued with the examination and the spo2 readings in the 80¿s.The customer claimed that the nurse entered the magnet room to give contrast to the patient and the patient was blue.A code was called, but the patient expired.The customer requested onsite assistance to check device functionality and to provide re-education to the nurses and staff using the device.The customer claimed that they were unsure if the patient¿s death was device-related, but the device was on the patient at the time the code had to be called.
Additional Manufacturer Narrative
H6: updated coding.H10: it was reported that the patient had a history of being overmedicated and being unarousable.It is unknown how this information relates to this incident.Multiple requests were made for additional information related to both the patient and the event itself, but no additional information was provided.Philips clinical product specialist (cps) visited the customer site per the customer¿s request.The cps found several items that could have been contributing factors to the device experiencing spo2 interference, all related to proper use, care and maintenance of the spo2 accessories.According to the cps, the spo2 cable itself was only halfway seated into the base of the wireless module.There are two screws used to affix the spo2 cable securely to the wireless module - one screw was found to not be attached causing the cable to wobble in and out of the actual connection since it was not secure.The cps removed the spo2 cable and inspected it further.Partial darkness was found in the light-emitting end of the cable, indicating that some of the fiber optics are damaged.Finally, it was found that 3 clips of the adult reusable spo2 clip were broken.As a result of this, the spo2 cable failed to remain in the clip.The above-referenced findings were reviewed with the customer.After the spo2 cable was completely attached to the base of the wireless module, no further movement of the cable was detected.Additionally, the customer indicated that they would be ordering a new spo2 cable.The cps also replaced the adult spo2 clip.Although several issues were identified related to proper use, care, and maintenance of the device¿s spo2 accessories, the investigation could not correlate these issues directly to the reported spo2 interference problem due to the limited information provided about the event.Review of the device¿s instructions for use found information and guidance related to proper use, care and maintenance of spo2 accessories.

• 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 14803530
• Report Number: 1051786-2022-00034
• Device Sequence Number: 11965320
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: 00884838039131
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152330
• 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?: Yes
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown