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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MICROSTREAM CO2 EXTENSION MULTIPARAMETER PATIENT MONITOR

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PHILIPS MEDICAL SYSTEMS MICROSTREAM CO2 EXTENSION MULTIPARAMETER PATIENT MONITOR Back to Search Results
Model Number M3015B
Device Problems Break (1069); Detachment of Device or Device Component (2907)
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.
 
Event Description
The customer reported "recurring microstream co2 extension tab breakages", which caused an intellivue multi measurement server x2 to fall off the monitor and onto the floor. No adverse event was reported.
 
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Brand NameMICROSTREAM CO2 EXTENSION
Type of DeviceMULTIPARAMETER PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM 71034
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key8686375
MDR Text Key147595684
Report Number9610816-2019-00140
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K110622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3015B
Device Catalogue Number865377
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 Received05/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2016
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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