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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM 4 PATIENT MONITOR; COMPACT PORTABLE PATIENT MONITORS
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PHILIPS MEDICAL SYSTEMS SURESIGNS VM 4 PATIENT MONITOR; COMPACT PORTABLE PATIENT MONITORS Back to Search Results
Model Number 863063
Device Problem Break (1069)
Patient Problem Fall (1848)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer contacted the customer care solution center and alleged that following an unspecified fall, the complaint device experienced several unspecified broken parts on the complaint device and requested support.The complaint device was not in clinical use at the time that the issue was discovered.There was no adverse event reported.
 
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Brand Name
SURESIGNS VM 4 PATIENT MONITOR
Type of Device
COMPACT PORTABLE PATIENT MONITORS
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 Key10096494
MDR Text Key193040177
Report Number1218950-2020-03127
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K052707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/18/2020
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 Number863063
Device Catalogue Number863063
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/18/2020
Initial Date FDA Received05/28/2020
Supplement Dates Manufacturer Received05/18/2020
Supplement Dates FDA Received06/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2012
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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