MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC SURESIGNS VM 6 PATIENT MONITOR

Model Number	863064
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
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 contacted the customer care solution center and alleged that the monitor on the complaint device freezes when adjusting parameters and that the screen was frozen and requested support.It is unknown if the complaint device was in clinical use at the time of the event.
Additional Manufacturer Narrative
An additional information response was received on (b)(6)2021 from the field.It was confirmed that the complaint device froze when activating the respiration alarm.Patient information was also provided.The complaint device was being returned to the manufacturer / customer service for inspection.No return dates have been provided for when the complaint device will be returned.
Event or Problem Description
The customer contacted the customer care solution center and alleged that the monitor on the complaint device freezes when adjusting parameters and that the screen was frozen and requested support.The device was in use on a patient.There was no report of patient or user harm.
Event or Problem Description
The customer contacted the customer care solution center and alleged that the monitor on the complaint device freezes when adjusting parameters and that the screen was frozen and requested support.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
An additional information response was received on 26may2021 from the field.It was also confirmed that the complaint device froze when activating the respiration alarm.Patient information was also provided.H3 other text: pending additional infromation.
Additional Manufacturer Narrative
Several good faith efforts were made to obtain additional information regarding customer resolution associated with this complaint, but there is no additional information available.Support engineer were engaged and working with the distributor for further troubleshooting and resolution via escalation case, source id: (b)(4).Final resolution is still ongoing and will be documented in the escalation case upon resolution.H3 other text : device not returned for evaluation.
Event or Problem Description
The customer contacted the customer care solution center and alleged that the monitor on the complaint device freezes when adjusting parameters and that the screen had frozen.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 6 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• MDR Report Key: 11810826
• Report Number: 8043836-2021-10003
• Device Sequence Number: 3793198
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: 00884838000049
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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?: No
• Distributor Facility Aware Date: 05/04/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021; 05/04/2021; 05/04/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/01/2021; 06/01/2021; 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 118