MAUDE Adverse Event Report: VYAIRE MEDICAL INC. RESUS, PED W/3 MASKS, 40" TBG, P/O; CARDIOPULMONARY RESUSCITATION AID

Model Number	RESUS, PED W/3 MASKS, 40" TBG, P/O
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for part number 2k8008br with lot number 0001090682 and udi code (b)(4) was reviewed in order to detect any issue related to the reported defect during its manufacture.The complete lot was manufactured, inspected, and released in 27aug2017 per our internal procedures and no issues were found.Based on the investigation since no sample or pictures were provided, we could not confirm the defect.Sample or pictures are needed to perform a better investigation.In addition, pfmea-08b was reviewed and we have the control for the reported failure mode.However, code 2k8010br was not added by mistake.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 at the connection where the ambu bag and hose come together, the breathing tubes are connecting like a friction slip and the standard is a lock connection.With the slip connect, any pressure pops the tube out rendering the device unusable.They attempted to use the sample on a patient but it blew apart multiple times.There was no harm reported.

• Brand Name: RESUS, PED W/3 MASKS, 40" TBG, P/O
• Common Device Name: CARDIOPULMONARY RESUSCITATION AID
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12370815
• Report Number: 8030673-2021-00190
• Device Sequence Number: 4346537
• Product Code: OEV
• UDI-Device Identifier: 10190752149731
• UDI-Public: (01)10190752149731(10)0001090682
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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: RESUS, PED W/3 MASKS, 40" TBG, P/O
• Device Catalogue Number: 2K8008BR
• Device Lot Number: 0001090682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1