MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number	AIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device or picture has not been returned for evaluation.Therefore, root cause has not been determined.Additionally, a device history record (dhr) of the lot number revealed no issues.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the oxygen tubing got disconnected from the wall (o2 source) when the o2 pressure increased.A gas leak was then observed from the airlife adult manual resuscitator.It happened during patient use, and the insufflator was replaced with a different brand.The incident did not cause any harm but did delay treatment.
Additional Manufacturer Narrative
Result of investigation: one sample of the p/n 2k8004f without lot number was received for the investigation.According to investigation, defect reported on this complaint was not confirmed, sample provided meet with all specifications.It is not necessary a root cause for this complaint.

• Brand Name: AIRLIFE ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10176899
• Report Number: 8030673-2020-00098
• Device Sequence Number: 11340203
• Product Code: OEV
• UDI-Device Identifier: 10190752114135
• UDI-Public: (01)10190752114135(10)0004075326
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2020

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: AIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, EXPIRATORY FILTER
• Device Catalogue Number: 2K8004F
• Device Lot Number: 0004075326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 09/05/2020
• 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