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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS OBTV REV G SURVEILLANCE AND ARCHIVE (SANDA) WITH HW/SW BUNDLED; PERINATAL MONTIORING SYSTEM
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PHILIPS MEDICAL SYSTEMS OBTV REV G SURVEILLANCE AND ARCHIVE (SANDA) WITH HW/SW BUNDLED; PERINATAL MONTIORING SYSTEM Back to Search Results
Model Number 865344
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the central station was producing no alarm sounds.The device was in use monitoring multiple patients at the time of the event.No adverse event involving patient or user was reported.
 
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
OBTV REV G SURVEILLANCE AND ARCHIVE (SANDA) WITH HW/SW BUNDLED
Type of Device
PERINATAL MONTIORING SYSTEM
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 Key7762264
MDR Text Key116613193
Report Number1218950-2018-06238
Device Sequence Number1
Product Code HGM
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K100420
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
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number865344
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2011
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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