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U.S. Department of Health and Human Services

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

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MAQUET CRITICAL CARE AB FLOW-I Back to Search Results
Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that before patient treatment, when a co2 absorber was installed, one of the two co2 absorber valves became dislocated from its original position.This resulted in a leakage.After the co2 absorber valve had been repositioned, the unit worked as intended again.There was no patient connected to the anesthesia workstation at the time of the event.(b)(4).
 
Manufacturer Narrative
A supplemental medwatch report will be provided when the investigation is finished.(b)(4).
 
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Brand Name
FLOW-I
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
Manufacturer Contact
magnus lindqvist
2 roentgenvagen
solna 17154
SW   17154
730770
MDR Report Key4403131
MDR Text Key21548676
Report Number8010042-2015-00003
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K133958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/16/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/16/2014
Initial Date FDA Received01/07/2015
Was Device Evaluated by Manufacturer? No
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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