MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC SURESIGNS VSI - NBP/SPO2/TEMP/WIRELESS

Model Number	863277
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
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 unit made a big flash while fse performing a safety test during a routine service and found the power entry module and power cord are burnt.The device was not in use on a patient at the time of the event.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the unit made a big flash while fse performing a safety test during a routine service and found the power entry module and power cord are burnt.The device was not in use on a patient at the time of the event.
Event or Problem Description
It was reported that the unit made a big flash while the fse was performing a safety test during routine service.There was no patient involvement.

• Brand Name: SURESIGNS VSI - NBP/SPO2/TEMP/WIRELESS
• Common Device Name: SURESIGNS VSI - NBP/SPO2/TEMP/WIRELESS
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer (Section G): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13595882
• Report Number: 1218950-2022-00160
• Device Sequence Number: 1930478
• Product Code: DXN
• UDI-Device Identifier: 00884838028388
• UDI-Public: 00884838028388
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112652
• 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: Health Professional
• Device Model Number: 863277
• Device Catalogue Number: 863277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2017
• 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