MAUDE Adverse Event Report: INVIVO CORPORATION MWI; PHYSIOLOGICAL PATIENT MONITOR

Model Number	866185
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.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.
Event or Problem Description
It was reported that an er doctor used the device during a code and claims the device didn't work.At this time, there is no information available as to the patient outcome or additional details about the device's reported failure to function.
Additional Manufacturer Narrative
H10: the customer requested philips' support in evaluating the device.A philips field service engineer (fse) was dispatched to the customer site and evaluated the device in question.No problems with the device were observed.The device was tested and verified to perform within manufacturer specifications.A good faith effort was made to obtain additional information associated with this complaint, but no additional information had been received.Fse evaluation of the device was unable to duplicate the reported issue.As a result, we are unable to conclude that the device caused or contributed to the adverse 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: MWI
• Common Device Name: PHYSIOLOGICAL PATIENT MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 10104247
• Report Number: 1051786-2020-00029
• Device Sequence Number: 13661750
• Product Code: MWI
• UDI-Device Identifier: 00884838039131
• UDI-Public: (01)00884838039131
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K152330
• 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): 05/21/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1