MAUDE Adverse Event Report: VYAIRE MEDICAL INC. RESUS, INF W/MASK, 40" TBG,P/O; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number RESUS, INF W/MASK, 40" TBG,P/O

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record for the part number 2k8010br with lot number 0001107228 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 on 02jun2017 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-(b)(4) 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 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, INF W/MASK, 40" TBG,P/O
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12370783
• MDR Text Key: 268251184
• Report Number: 8030673-2021-00191
• Device Sequence Number: 1
• Product Code: OEV
• UDI-Device Identifier: 10190752149748
• UDI-Public: (01)10190752149748(10)0001107228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: RESUS, INF W/MASK, 40" TBG,P/O
• Device Catalogue Number: 2K8010BR
• Device Lot Number: 0001107228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1