MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT

Catalog Number A4UX2044

Device Problem Blocked Connection (2888)

Patient Problem Hypoxia (1918)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, vyaire has not received the suspect device for evaluation.

Event Description

Medwatch report mw5087863: air could not be exchanged through the circuit filter; the patient was intubated three times before identifying the problem; the circuit filter was replaced and the problem was resolved; no harm to the patient.

• Brand Name: VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; 85 industrial mexicali; mexicali, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8902963
• MDR Text Key: 154629282
• Report Number: 8030673-2019-00049
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752137349
• UDI-Public: (01)10190752137349(10)0004073768(11)190115
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A4UX2044
• Device Lot Number: 0004073768
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• 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
• Patient Outcome(s): Required Intervention