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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS VS4 VITAL SIGNS MONITOR; PATIENT MONITOR
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PHILIPS MEDICAL SYSTEMS VS4 VITAL SIGNS MONITOR; PATIENT MONITOR Back to Search Results
Model Number 863283
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.
 
Event Description
The customer reported that the temp probe module has damage.The device was not in clinical use at the time the issue was discovered.
 
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Brand Name
VS4 VITAL SIGNS MONITOR
Type of Device
PATIENT 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 Key11712170
MDR Text Key249242883
Report Number1218950-2020-06514
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00884838087095
UDI-Public(01)00884838087095
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863283
Device Catalogue Number863283
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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