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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 Problems Detachment Of Device Component (1104); Component Falling (1105); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that "we are experiencing the vs 4 monitors coming loose from the bracket they are sitting on.It is as if after being moved and turned the bolt/nut comes loose allowing the machine to slide right off the platform.We have had bio-med tighten all the monitors again, however we have had a couple instances in which the monitor fell off and just missed hitting the patient in the head.We need to know if there are other options for locking bolts, or a device that can go around the monitor so if the bolt comes loose it does not fall".There was no reported patient impact.
 
Event Description
The customer reported that "we are experiencing the vs 4 monitors coming loose from the bracket they are sitting on.It is as if after being moved and turned the bolt/nut comes loose allowing the machine to slide right off the platform.We have had bio-med tighten all the monitors again, however we have had a couple instances in which the monitor fell off and just missed hitting the patient in the head.We need to know if there are other options for locking bolts, or a device that can go around the monitor so if the bolt comes loose it does not fall".There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.The device was in use at the time of the reported issue.
 
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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
wendy chadbourne
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6222780
MDR Text Key64171647
Report Number1218950-2017-00065
Device Sequence Number1
Product Code DXN
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 health professional,user faci
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number863283
Device Lot Number2016-06
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2016
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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