MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO 2010 REV-C-EXCHANGE

Model Number	453564621791
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the power supply had an electrical burn and produced sparks between the power supply and power cable.When philips went onsite, found that the customer had already isolated the cable at both ends and removed the power supply from the theatre.The device was not in clinical use at the time the issue occurred.There as no adverse event or user/patient harm reported.
Event or Problem Description
It was reported that the power supply had an electrical burn and produced sparks between the power supply and power cable.When philips went onsite, found that the customer had already isolated the cable at both ends and removed the power supply from the theatre.The device was not in linical use at the time the issue occurred.There was no adverse event or user/patient harm reported.A philips field service engineer (fse) went to the customer site and confirmed the reported problem.When onsite, the fse found that customer had already isolated the cable at both ends and removed the power supply from the theatre.The power plug was found to have melted.The fse inspected the frontend and found no signs of burns or damage to the connector.The fse inspected the table tray and found no signs of liquid but a few drops of contrast.The network and data cable was found to have some minor abrasions to the outer insulation.The fse fitted the new power supply and used a hospital supplied power cable, which was connected to the power outlet on the table to feed power to the frontend.The fse carried out electrical safety test and functional testing.The fse noted that the uninterruptable power supply (ups) was dropping power every few seconds after it was turned on, possibly caused by the fact it was trying to draw too much current when the power supply sparked.After the power supply was isolated from the table and bypassed to maintain clinical use of the system, the cable plug was burnt badly and in need of replacement.The cable conductors were cut back and inspected for tarnishing and integrity and were found to be in good order so a new iec plug top was fitted and tested.However the ups that was feeding this cable was also showing signs of failure and needed replacing.Another fse later went to the site, and replaced the ups.No further investigation or action is warranted at this time.
Additional Manufacturer Narrative
Box d: additional information received indicating product serial number reported in the initial problem report was incorrect.The serial number has been updated to 1211.Product brand name, model number, and gtin been updated to better reflect the reported product.

• Brand Name: XPER FLEX CARDIO 2010 REV-C-EXCHANGE
• Common Device Name: XPER FLEX CARDIO 2010 REV-C-EXCHANGE
• 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: jeanne ahearn ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 15775446
• Report Number: 3003768277-2022-00882
• Device Sequence Number: 17604929
• Product Code: MWI
• UDI-Device Identifier: 00884838084926
• UDI-Public: 00884838084926
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• 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: Other
• Device Model Number: 453564621791
• Device Catalogue Number: 722458
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2016
• 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