MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number	2K8040
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, vyaire has not received the sample for evaluation.
Event or Problem Description
The customer reported the airlife infant manual resuscitator are falling apart during a code.The customer reported an alternative manual resuscitator was found and used.The customer reported there is no patient consequence associated with the event.
Additional Manufacturer Narrative
At this time, vyaire medical has not received the sample for investigation.If additional information or the sample is received, a supplemental report will be submitted.
Event or Problem Description
Ambu bags falling apart during a code.

• Brand Name: AIRLIFE
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8218324
• Report Number: 8030673-2019-00021
• Device Sequence Number: 1710370
• Product Code: OEV
• UDI-Device Identifier: 10885403171130
• UDI-Public: (01)10885403171130(10)0001143879
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2K8040
• Device Catalogue Number: 2K8040
• Device Lot Number: 0001143879
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention