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

Model Number AH202

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

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 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
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; 85 parque undustrial mex iii; mexicali, 21397 ; MX 21397
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il ; 7570116
• MDR Report Key: 9895033
• MDR Text Key: 202728467
• Report Number: 8030673-2020-00091
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 10190752145153
• UDI-Public: (01)10190752145153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AH202
• Device Catalogue Number: AH202
• Device Lot Number: 0004125773
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1