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

Model Number	863064
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that on (b)(6) 2022, in room 7 of the neonatology department, a bradycardia and desaturation alarm would not have sounded.The baby's heart rate was 42 for an alarm limit setting between 80 and 180.It was reported to philips that the alleged failure was observed while the device was in use on a patient.However, no adverse patient impact was reported by the customer.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
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 on (b)(6) 2022, in room 7 of the neonatology department, a bradycardia and desaturation alarm would not have sounded.The baby's heart rate was 42 for an alarm limit setting between 80 and 180.It was reported to philips that the alleged failure was observed while the device was in use on a patient.However, no adverse patient impact was reported by the customer.
Additional Manufacturer Narrative
H3 other text : no response from the customer to have the device repaired.
Event or Problem Description
It was reported to philips that on 02/09/2022, in room 7 of the neonatology department, a bradycardia and desaturation alarm would not have sounded.The baby's heart rate was 42 for an alarm limit setting between 80 and 180.No adverse patient impact was reported by the customer.

• 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: 13560110
• Report Number: 1218950-2022-00135
• Device Sequence Number: 4313563
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: 00884838000049
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2008
• 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