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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2 PATIENT MONITOR

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PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2 PATIENT MONITOR Back to Search Results
Model Number 863276
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Unable to confirm device serial number. A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the patient monitor shows a loudspeaker fault. The customer confirmed that the device was not connected to a patient when this event happened. There was no reported adverse event to patient or user.
 
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Brand NameSURESIGNS VSI - NBP/SPO2
Type of DevicePATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8267313
MDR Text Key133757267
Report Number1218950-2019-00660
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 foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863276
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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