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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE ARTERIAL BLOOD SAMPLER; ARTERIAL BLOOD SAMPLING KIT
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VYAIRE MEDICAL AIRLIFE ARTERIAL BLOOD SAMPLER; ARTERIAL BLOOD SAMPLING KIT Back to Search Results
Model Number AIRLIFE® ARTERIAL BLOOD SAMPLER
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Event Description
The customer reported that the airlife® arterial blood sampler experienced not pumping up.The customer confirmed that there was no patient harm associated with the reported event.
 
Manufacturer Narrative
Customer did not sent pictures or the physical sample, additionally the device history record for the reported lot number was reviewed but no issues were found.However the lot number 0004165763 is related to other complaints with the same issue.Therefore, the defect was confirmed, pma/ 510(k): enforcement discretion.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
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Brand Name
AIRLIFE ARTERIAL BLOOD SAMPLER
Type of Device
ARTERIAL BLOOD SAMPLING KIT
Manufacturer (Section D)
VYAIRE MEDICAL
510 technology dr
irvine IL 92618
MDR Report Key12561422
MDR Text Key283619628
Report Number8030673-2021-00199
Device Sequence Number1
Product Code OFP
UDI-Device Identifier10190752155084
UDI-Public(01)10190752155084(10)0004165763
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAIRLIFE® ARTERIAL BLOOD SAMPLER
Device Catalogue Number9025TRU
Device Lot Number0004165763
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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