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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review. Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
The customer reported that the system is broken. The device was not in clinical use at the time the issue was discovered. There was no adverse event or patient harm reported.
 
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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
kimberly shelly
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11686314
MDR Text Key248433041
Report Number1218950-2020-06419
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00884838028371
UDI-Public(01)00884838028371
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,user facility
Reporter Occupation
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863276
Device Catalogue Number863276
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/23/2017
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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