MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION INFORMATION PORTAL (IP5)

Model Number	865471
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested to clarify the details of this event.An initial response was provided that indicated that the philips ip5 complaint device was mistakenly taken into the mri procedure room by auxiliary staff at the user facility.It was confirmed that the complaint device was not mounted to a cart but was carried into the mri procedure room.It is currently unknown at which point the complaint device was pulled into the mri machine.Additional information provided from the field also indicated that the mri device that the philips ip5 monitor complaint device was pulled into was manufactured by general electric.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the monitor entered the mri room and broke when pulled into it.There was no patient involvement.
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site.Several good faith effort (gfe) attempts were made to the service technicians in order to clarify the complaint device evaluation and resolution.The philips engineer indicated that the issue was associated with the customer transporting the philips ip5 expression information portal device into the mri procedure room, where it was magnetically pulled into the general electric mri device.As this event was indicated by the philips engineer to have been related to customer error, this event will not be considered to be a malfunction of the complaint device.It is currently unknown how the issue was resolved as the engineer indicated that it was not possible to repair the equipment, and the customer had not accepted a quote for the device replacement as of the date of complaint closure.No further investigation or action is warranted at this time.
Event or Problem Description
It was reported that the monitor entered the mri room and broke when pulled into it.There was no patient involvement.

• Brand Name: EXPRESSION INFORMATION PORTAL (IP5)
• Common Device Name: EXPRESSION INFORMATION PORTAL (IP5)
• 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12739362
• Report Number: 1051786-2021-10067
• Device Sequence Number: 4098865
• Product Code: MWI
• UDI-Device Identifier: 00884838031890
• UDI-Public: 00884838031890
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,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: 865471
• Device Catalogue Number: 865471
• 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: 10/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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