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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS OB TRACEVUE SERVER; OB INFORMATION MANAGEMENT SYS
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PHILIPS MEDICAL SYSTEMS OB TRACEVUE SERVER; OB INFORMATION MANAGEMENT SYS Back to Search Results
Model Number 865074 (M1383F)
Device Problem No Display/Image (1183)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported to philips healthcare that the display of the heartstart xl was "bule".There was no reported pt impact.
 
Manufacturer Narrative
(b)(4).A follow up report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
Pr#: (b)(4).Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
OB TRACEVUE SERVER
Type of Device
OB INFORMATION MANAGEMENT SYS
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
Manufacturer Contact
denyse murphy
3000 minuteman rd.
andover, MA 01810
9786597844
MDR Report Key3700325
MDR Text Key16804328
Report Number1218950-2014-00679
Device Sequence Number1
Product Code HGM
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K081203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/15/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865074 (M1383F)
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/08/2010
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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