MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Model Number	AH202
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of now, the sample has not been returned for evaluation.The customer reported that in one incident, the nurse did not place the temperature probe back into the circuit, but she did use the blue cap to seal the circuit.This action left the temperature probe exposed to the atmospheric room temperature and the heater responded by heating the circuit to an unsafe level.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the temperature probe slips out of the temperature port of ah202 airlife adult heated wire circuit kit at the humidifier connection.The customer stated that there was no patient harm associated with this reported event.

• Brand Name: AIRLIFE
• Common Device Name: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9895033
• Report Number: 8030673-2020-00091
• Device Sequence Number: 2497270
• Product Code: OFP
• UDI-Device Identifier: 10190752145153
• UDI-Public: (01)10190752145153
• 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: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: AH202
• Device Catalogue Number: AH202
• Device Lot Number: 0004125773
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1