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

Model Number	863276
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
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 reported an audio failure.Patient involvement is unknown.
Event or Problem Description
The customer reported audio failure message and no sound.Patient involvement is unknown.There was no reported patient impact / injury.
Additional Manufacturer Narrative
The device did not behave as expected by the customer.According to the case closure notes, the issue was resolved by the customer and no work performed by philips.To resolve the issue, the device was restarted and the message went away.Although the reported issue was resolved by restarting the device, it is not known what caused the customer's issue initially.H3 other text : the issue was resolved by the customer.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Common Device Name: SURESIGNS VSI - NBP/SPO2
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• MDR Report Key: 12141770
• Report Number: 1218950-2021-10703
• Device Sequence Number: 17098688
• Product Code: DXN
• UDI-Device Identifier: 00884838028371
• UDI-Public: 00884838028371
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112652
• Number of Events Summarized: 1
• Summary Report (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: 863276
• Device Catalogue Number: 863276
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/29/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1