MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE; FLOW-INFLATING RESUSCITATION BAGS

Catalog Number 5404BDL1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to vyaire that the.5 liter resuscitation bag ripped during use.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: AIRLIFE BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE
• Type of Device: FLOW-INFLATING RESUSCITATION BAGS
• 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, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8755180
• MDR Text Key: 149850521
• Report Number: 8030673-2019-00045
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5404BDL1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/06/2019
• 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