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

Catalog Number B1714XXX

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported that one box of circuits were found to be "falling apart".Hoses keep popping off while in use.No patient compromise.

• Brand Name: VITAL SIGNS PEDIATRIC 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 parque industrial; mexicali, mex 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8622131
• MDR Text Key: 145511844
• Report Number: 8030673-2019-00042
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10885403244391
• UDI-Public: (01)10885403244391(10)0004052958(11)180822
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B1714XXX
• Device Lot Number: 0004052958
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2019
• 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