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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
Model Number C30
Device Problems Leak/Splash (1354); Tidal Volume Fluctuations (1634); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/26/2014
Event Type  malfunction  
Event Description
It was reported that during patient treatment, the tidal volume decreased after replacing the co2 absorber.The patient cassette was found slightly dislodged from its original position and thus causing a leakage resulting in the reported tidal volume decrease.There was no patient harm reported.(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 C30
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
Manufacturer Contact
magnus lindqvist
2 roentgenvagen
solna 17154
SW   17154
7307705
MDR Report Key4403178
MDR Text Key18068115
Report Number8010042-2015-00005
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeJA
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,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/26/2014
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 Model NumberC30
Device Catalogue Number6677300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/26/2014
Initial Date FDA Received01/07/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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