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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30

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MAQUET CRITICAL CARE AB FLOW-I C30 Back to Search Results
Catalog Number 6677300
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 09/09/2014
Event Type  malfunction  
Event Description
It was reported that during a pre check a message absorber was prompted on the screen indicating that no co2 absorber was attached.The problem was caused by the pt cassette being dislocated.There was no pt harm reported.(b)(4).
 
Manufacturer Narrative
Further info and defective parts have been requested.A supplemental medwatch report will be provided when the investigation is finished.Refer to (b)(4).
 
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Brand Name
FLOW-I C30
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
Manufacturer (Section G)
MAQUET CRITICAL CARE AB
solna 1715 4
SW   17154
Manufacturer Contact
janice pevide
45 barbour pond drive
wayne, NJ 07470
9737097753
MDR Report Key4144342
MDR Text Key20296657
Report Number8010042-2014-00422
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
133958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/23/2014,09/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6677300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/17/2014
Device Age21 MO
Event Location Hospital
Initial Date Manufacturer Received 09/09/2014
Initial Date FDA Received09/23/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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