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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE PERINATAL ADV SYS, INTEG ED; PERINATAL MONTIORING SYSTEM
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PHILIPS MEDICAL SYSTEMS INTELLISPACE PERINATAL ADV SYS, INTEG ED; PERINATAL MONTIORING SYSTEM Back to Search Results
Model Number 866133
Device Problem No Audible Alarm (1019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.(b)(4).
 
Event Description
The customer reported that the alarms don't sound on a web client.There is no report of a negative user/patient outcome.
 
Event Description
The customer reported that the alarms don't sound on a web client.The device was used for patient monitoring.There is no report of an adverse event.
 
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Brand Name
INTELLISPACE PERINATAL ADV SYS, INTEG ED
Type of Device
PERINATAL MONTIORING SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
böeblingen 71034
GM  71034
Manufacturer Contact
wendy chadbourne
hewlett-packard str.2
böeblingen 71034
GM   71034
MDR Report Key5096842
MDR Text Key26738889
Report Number9610816-2015-00206
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,user facility
Reporter Occupation Other
Type of Report Followup
Report Date 08/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number866133
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2014
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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