MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM; PHYSIOLOGICAL PATIENT MONITOR

Model Number	865214
Health Effect - Clinical Code	No Patient Involvement (2645)
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 biomed reported that the wireless module was sent to the shop because the battery was stuck in the wireless module.The device was not in use on a patient.
Additional Manufacturer Narrative
The battery supplier determined through evaluation of the returned battery that the kapton tape covering the battery¿s pca was punctured and made contact with the pcba, causing a short.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM
• Common Device Name: PHYSIOLOGICAL PATIENT MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 8598963
• Report Number: 1051786-2019-00019
• Device Sequence Number: 11390123
• Product Code: MWI
• UDI-Device Identifier: 00884838016064
• UDI-Public: (01)00884838016064
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K090785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 865214
• Device Catalogue Number: 865214
• Device Lot Number: 0000028870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1