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U.S. Department of Health and Human Services

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

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PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC SURESIGNS VSI - NBP Back to Search Results
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.
 
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Brand NameSURESIGNS VSI - NBP
Type of DeviceSURESIGNS VSI - NBP
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
derek sammarco
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key12008526
MDR Text Key256473808
Report Number1218950-2021-10654
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863275
Device Catalogue Number863275
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/09/2021
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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