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

Model Number	863275
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the problem of a loudspeaker is defective.The device was not in use on a patient at the time of the event.
Additional Manufacturer Narrative
A part quotation was provided and the customer did not accept it.It is not known how or if the customer's issue was resolved.Because of this, we are considering this to be a malfunction of insufficient information/cause unknown.The device remains at the customer site, and no subsequent calls have been logged for this device/issue.H3 other text : a part quotation was provided and the customer did not accept it.
Event or Problem Description
The customer reported that the loudspeaker is defective.The device was not in clinical use at the time the reported issue was discovered.

• Brand Name: SURESIGNS VSI - NBP
• Common Device Name: SURESIGNS VSI - NBP
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• MDR Report Key: 12008526
• Report Number: 1218950-2021-10654
• Device Sequence Number: 16918188
• Product Code: DXN
• UDI-Device Identifier: 00884838028364
• UDI-Public: 00884838028364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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: 863275
• Device Catalogue Number: 863275
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/09/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1