MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 6 PATIENT MONITOR

Model Number	863064
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported an unspecified alarm failure.There was no patient involvement.
Additional Manufacturer Narrative
The customer contacted the customer care solution center (ccsc).The customer requested that a philips remote service engineer (rse) contact the customer.Rse provided the related information to customer by phone.The device remains at customer site.There was no malfunction of the device.Philips will not consider this as a malfunction.No further investigation or action is warranted.If the customer is in need of further assistance, a new service order will be opened.
Event or Problem Description
It was reported to philips that while not in clinical use, the customer received the fco files.The customer wants to know about the fco files via hot line.The device is running normal.There was no patient involvement.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 6 PATIENT MONITOR
• 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: 13316066
• Report Number: 1218950-2022-00059
• Device Sequence Number: 14642719
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: 00884838000049
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility
• 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: 863064
• Device Catalogue Number: 863064
• 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: 01/07/2022
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown