MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number	AIRLIFE¿ MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.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 tube of airlife adult manual resuscitator, variable volume oxygen reservoir tubing, adult mask comes out and cannot be reattached.The issue occurred during patient-use and the customer confirmed that there was no patient harm associated with this reported event.
Additional Manufacturer Narrative
Result of investigation: the device history record (dhr) review did not show any deviations to manufacturer specification.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.
Additional Manufacturer Narrative
Result of investigation: 15 open samples of the p/n 2k8017 without lot number were received for the investigation, samples were evaluated and found 14 samples defectives, the oxygen line (tubing) is disconnected from threaded o2 housing and also found some threaded o2 housing broken, these samples were handled by the customer and it is possible that they damaged the components.It was also observed in the photograph that the oxygen line (tubing) is disconnected from threaded o2 housing.Vyaire found that if mix adhesive used on the assemble with alcohol provoke that tubing could disconnect.The alcohol affect the effective of the adhesive.

• Brand Name: AIRLIFE MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10292953
• Report Number: 8030673-2020-00111
• Device Sequence Number: 11586739
• Product Code: OEV
• UDI-Device Identifier: 10190752114296
• UDI-Public: (01)10190752114296(10)0004068224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE¿ MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK
• Device Catalogue Number: 2K8017
• Device Lot Number: 0004068224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/17/2020; 09/17/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/12/2020; 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1