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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation. It is unknown at the time of this report if the device caused or contributed to the adverse event. Additional information has been requested.
 
Event Description
The customer reported that measured readings were obtained from a deceased patient.
 
Manufacturer Narrative
Customer care resolution center (ccsc) provided troubleshooting assistance. Safety and functional tests were done and the device passed all testing. A comprehensive log analysis also confirmed no product malfunction. The field service engineer (fse) replaced the device battery during testing ,but not for the purpose of addressing the reported issue. This complaint has been evaluated and does not allege a death, serious injury, or safety issue. The deputy ward manager at the customer side, confirmed on (b)(6)-2018 that the death of the patient was not related to the behavior of the device. The device remains at the customer site. There have been no additional calls from the customer.
 
Event Description
The customer reported that the following values were measured in a deceased patient: 14. 10. 2018/15:35:38 pulse 77, spo2 89%, rr -/-, temp. 34. 4.
 
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Brand NameVS4 VITAL SIGNS MONITOR
Type of DevicePATIENT MONITOR
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 Key7996003
MDR Text Key124719332
Report Number1218950-2018-08317
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K120132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 10/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863283
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2013
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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