MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER IM HARDWARE

Model Number	453564243601
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during use the system will pause, and the display will freeze momentarily, then will run fast to catch up to real time, making the waveform look like asystole.The device was in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.
Event or Problem Description
The customer reported that during use, the system will pause, and the display will freeze momentarily, then will run fast to catch up to real time, making the waveform look like asystole (flatline).According to the customer, each time that it happened, they would reboot the device and the workstation in order to get the flex 2020 to function correctly.The device was in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.

• Brand Name: XPER IM HARDWARE
• Common Device Name: XPER IM HARDWARE
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• MDR Report Key: 12296104
• Report Number: 1051786-2021-10043
• Device Sequence Number: 3164616
• Product Code: MWI
• UDI-Device Identifier: 00884838083530
• UDI-Public: 00884838083530
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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: 453564243601
• Device Catalogue Number: 453564243601
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/30/2021
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1