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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 Break (1069); Device Fell (4014)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer reported to philips that their co2 microstream extension module had a broken latch and was dropped because of the damaged latch.No patient involvement.
 
Manufacturer Narrative
This report was transmitted under the incorrect registration number.Please refer to mdr 9610816-2019-00332 for correct report.
 
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Brand Name
MICROSTREAM CO2 EXTENSION
Type of Device
MICROSTREAM CO2 EXTENSION
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key9470924
MDR Text Key176811524
Report Number1218950-2019-09459
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838083585
UDI-Public(01)00884838083585
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3015A
Device Catalogue Number867041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2019
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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