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

Model Number 863275

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 256473808
• Report Number: 1218950-2021-10654
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884838028364
• UDI-Public: 00884838028364
• Combination Product (y/n): N
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863275
• Device Catalogue Number: 863275
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/09/2021
• Date Manufacturer Received: 06/09/2021
• Patient Sequence Number: 1