MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ASSY PAT CIR W/O PEEP ADT SPU 10PK; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number 29657-001

Device Problems Disconnection (1171); Material Separation (1562); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by vyaire that the complaint sample is available for evaluation.A ups shipping label has been sent out to the customer to send in the impacted sample.A follow up emdr will be submitted upon completion of the complaint investigation.(b)(4).

Event Description

The customer reported during a transfer "patient was being moved from a wheelchair to a bed the peep valve separated from the circuit and the rubber valve shot out into the air.Patient had been on circuit for 14 days.Witnessed by aid there was an audible alarm on the ventilator".There was no patient or user harm related to this reported failure.The circuit was changed out.The customer confirmed that the patient did not have any respiratory distress or a need for manual ventilation during this reported event.The clinician was bedside when the disconnection occurred and the circuit was changed out immediately.Customer also confirmed that the there was no tension on the circuit when it disconnected.

Manufacturer Narrative

Device evaluation: one open sample was received for evaluation.Visual testing observed that the diaphragm, exhale valve was detached therefore the reported failure mode was confirmed.After a thorough evaluation of the manufacturing procedure it was found that personnel could have contributed to the reported failure.The manufacturing procedure states a recommended time of curing.The manufacturing procedure was not followed resulting in the reported failure.Personnel have been retrained.

• Brand Name: ASSY PAT CIR W/O PEEP ADT SPU 10PK
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 6745195
• MDR Text Key: 81112221
• Report Number: 8030673-2017-00357
• Device Sequence Number: 1
• Product Code: CAI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 29657-001
• Device Lot Number: 0001091757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention