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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MICROSTREAM CO2 EXTENSION
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PHILIPS MEDICAL SYSTEMS MICROSTREAM CO2 EXTENSION Back to Search Results
Model Number M3015A
Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported on (b)(6) 2020 at 16:30 pm, their microstream co2 extension stopped working and a message ¿mms equipment fault¿ appeared.There was an adverse event reported.No further information regarding the reported issue or patient were available at the time of the reporting.
 
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.
 
Event Description
The customer reported on (b)(6)2020 at 16:30 pm, their microstream co2 extension stopped working and a message ¿mms equipment fault¿ appeared.T he customer confirmed that there were no patient harm.
 
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Brand Name
MICROSTREAM CO2 EXTENSION
Type of Device
MICROSTREAM CO2 EXTENSION
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key10406979
MDR Text Key202903086
Report Number9610816-2020-00280
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
PMA/PMN Number
K993383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3015A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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