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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV BLOWER MISTER WITH IV SETS; LAVAGE, JET
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MAQUET CV BLOWER MISTER WITH IV SETS; LAVAGE, JET Back to Search Results
Catalog Number C-CB-1000
Device Problems Obstruction of Flow (2423); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
 
Event Description
Hospital opened 3 devices from the same lot 96255607 and the co2 would not flow and discovered they were occluded.They had 6 blower mister with iv sets left in stock and want them to be exchanged for a different lot #.A total of 9 devices will be returned.
 
Manufacturer Narrative
Internal complaint # (b)(4).Autonumber # (b)(4).Added device code [2991] no flow.The certificate of conformance was reviewed.The vendors conform that the device lot conforms to all applicable product specifications.There were no non-conformities observed.The device was returned to the factory in a sealed package.A visual inspection was conducted.No signs of clinical use and no evidence of blood was observed.The package was returned intact, no visible defects were observed.While the device was not opened and inspected, the investigation from the supplier the reported failure mode ¿no flow¿ is an inherent issue due to supplier deficiency.An ncmr, scar, and hhe have been issued for reported lot number and a shipping hold has been issued.Specific actions for the reported confirmed failure mode are being maintained and documented under maquet¿s scar system.Specific actions for the reported confirmed failure mode are being maintained and documented under maquet's health hazard evaluation (hhe) system.
 
Event Description
Hospital opened 3 devices from the same lot 96255607 and the co2 would not flow and discovered they were occluded.They had 6 blower mister with iv sets left in stock and want them to be exchanged for a different lot #.A total of 9 devices will be returned.
 
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Brand Name
BLOWER MISTER WITH IV SETS
Type of Device
LAVAGE, JET
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8044586
MDR Text Key126523040
Report Number2242352-2018-01107
Device Sequence Number0
Product Code FQH
PMA/PMN Number
K983135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/02/2018
Device Catalogue NumberC-CB-1000
Device Lot Number96255607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Date Manufacturer Received01/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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