MAUDE Adverse Event Report: AIRLIFE¿ ADULT SINGLE-LIMB PORTABLE VENTILATOR CIRCUIT; SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Model Number	AIRLIFE¿ ADULT SINGLE-LIMB PORTABLE VENTILATOR CIRCUIT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Any additional information received from the customer will be included in a follow-up report.The customer confirmed that there are no samples to return and no photos available for evaluation.
Event or Problem Description
The customer reported that the 001795 circuit vent vol f/port 10/cs experienced two (2) transport circuits caused patient ventilator to alarm with proxy line check circuit code.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: AIRLIFE¿ ADULT SINGLE-LIMB PORTABLE VENTILATOR CIRCUIT
• Common Device Name: SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
• MDR Report Key: 10382897
• Report Number: 8030673-2020-00116
• Device Sequence Number: 17035114
• Product Code: BZO
• UDI-Device Identifier: 10190752144729
• UDI-Public: (01)10190752144729
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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¿ ADULT SINGLE-LIMB PORTABLE VENTILATOR CIRCUIT
• Device Catalogue Number: 001795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/07/2020
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1