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 Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

As of this time, has been shipped for investigation.However, the customer confirmed that the sample is available.As an intervention, an ambu bag was required to be used until it was replaced with a new circuit.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the adu520x4d vital signs adult anesthesia breathing circuit experienced circuit malfunction due to plastic piece covering the air exchange circuit filter during use.The customer confirmed that there was no patient harm associated with this reported event.As an intervention, a manual ventilation was required to be used until it was replaced with a new circuit.

Manufacturer Narrative

Result of investigation: one opened sample of the p/n adu520x4d without lot number was received for the investigation.According to investigation, we determined that personnel are related with defect reported, since they did not follow the process to perform change proper the media roll.Also process is related with defect reported, since it is not very clear to perform the change of the roll plush.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• MDR Report Key: 10268596
• MDR Text Key: 203102344
• Report Number: 8030673-2020-00103
• 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: 07/13/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/31/2020
• 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