MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE SINGLE LIMB PATIENT CIRCUIT; HEATED AND NON-HEATED BREATHING CIRCUITS

Model Number AIRLIFE¿ SINGLE LIMB PATIENT CIRCUIT

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.The customer stated that return sample is not available and no photos provided.No root cause has been determined.

Event Description

The customer reported that the airlife¿ single limb patient circuit is causing the vent alarm to show low pressure.At this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: AIRLIFE SINGLE LIMB PATIENT CIRCUIT
• Type of Device: HEATED AND NON-HEATED BREATHING CIRCUITS
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v?a de la producci?n; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il ; 3273284
• MDR Report Key: 10359978
• MDR Text Key: 203883726
• Report Number: 8030673-2020-00112
• Device Sequence Number: 1
• Product Code: CAI
• 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: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE¿ SINGLE LIMB PATIENT CIRCUIT
• Device Catalogue Number: 1574792
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1