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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS VM6; COMPACT PORTABLE PATIENT MONITORS
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PHILIPS MEDICAL SYSTEMS VM6; COMPACT PORTABLE PATIENT MONITORS Back to Search Results
Model Number 863064
Device Problems Image Display Error/Artifact (1304); Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that their vm6 monitor has no sound and a red screen.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.
 
Event Description
The customer reported that their vm6 monitor has no sound.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.
 
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Brand Name
VM6
Type of Device
COMPACT PORTABLE PATIENT MONITORS
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
denyse murphy
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6600418
MDR Text Key76403954
Report Number1218950-2017-03641
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K082280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863064
Device Catalogue Number863064
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/08/2017
Initial Date FDA Received05/31/2017
Supplement Dates Manufacturer Received05/08/2017
Supplement Dates FDA Received08/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2014
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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