MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM8 IBP EXCHG UNIT W/RECORDER

Model Number	453564024481
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Poor Quality Image (1408); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
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 to philips that the device displayed color bar, then froze and powered off.It was unknown if the device was in clinical use at the time the issue was discovered.No adverse event or patient harm was reported.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to philips that the device displayed color bar, then froze and powered off.It was unknown if the device was in clinical use at the time the issue was discovered.No adverse event or patient harm was reported.
Additional Manufacturer Narrative
The device was received by the philips bench repair and an evaluation was performed by the bench technician.The reported issue was confirmed and traced to a faulty mainboard.The small parts kit (lcd cable) and the nbp pump also had to be replaced for compatibility.The device was returned to the customer after parts replacement.
Event or Problem Description
It was reported to philips that the device displayed color bar, then froze and powered off.This was discovered by the biomedical engineer onsite while conducting maintenance on the unit.The device was not in use on a patient at the time of event, there was no patient involvement.

• Brand Name: SURESIGNS VM8 IBP EXCHG UNIT W/RECORDER
• Common Device Name: SURESIGNS VM8 IBP EXCHG UNIT W/RECORDER
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13599664
• Report Number: 1218950-2022-00161
• Device Sequence Number: 14896047
• Product Code: MHX
• UDI-Device Identifier: 00884838000087
• UDI-Public: 00884838000087
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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: 453564024481
• Device Catalogue Number: 453564024481
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 04/24/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2008
• 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