MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE ARTERIAL BLOOD SAMPLER; ARTERIAL BLOOD SAMPLING KIT

Model Number	AIRLIFE® ARTERIAL BLOOD SAMPLER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.

• Brand Name: AIRLIFE ARTERIAL BLOOD SAMPLER
• Common Device Name: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• MDR Report Key: 12561422
• Report Number: 8030673-2021-00199
• Device Sequence Number: 16453976
• Product Code: OFP
• UDI-Device Identifier: 10190752155084
• UDI-Public: (01)10190752155084(10)0004165763
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE® ARTERIAL BLOOD SAMPLER
• Device Catalogue Number: 9025TRU
• Device Lot Number: 0004165763
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1