MAUDE Adverse Event Report: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire has not received the suspect device/component for evaluation.Therefore, no root cause could be determined yet.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 following intubation, one of the two vital signs adult anesthesia breathing circuit, attachment pieces that provide air exchange and oxygenation had a malfunctioned due to a plastic piece covering the entirety of the air exchange circuit filter.This prevented any air exchange from happening.This resulted in the patient not receiving oxygenation, requiring manual ventilation to be used until it was replaced with a new circuit.At this time, there is no information regarding patient harm associated with the reported event.

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.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• MDR Report Key: 10261392
• MDR Text Key: 203094592
• Report Number: 8030673-2020-00102
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10190752121539
• UDI-Public: (01)10190752121539(10)0004143192
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
• Device Catalogue Number: ADU520X4D
• Device Lot Number: 0004143192
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention