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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 Problem Therapeutic or Diagnostic Output Failure (3023)
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 called philips to report that their co2 module extension was not being recognized by the associated connected monitor.No known patient involvement.
 
Manufacturer Narrative
This complaint was reported in error.Philips does not consider the allegation of a module failing to be recognized a reportable event according to the following rationale - "the module was not recognized.The issue is associated with inop/error indicators that the module in use cannot be identified by the system therefore measurement would be impacted.The user would identify the issue during routine use and arrange for alternate means of monitoring as warranted." 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
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 Key10078795
MDR Text Key192006835
Report Number9610816-2020-00162
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 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3015A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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