MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ANESTHSIA CIRCUIT ADULT-LF

Catalog Number DYNJAAF6718

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unidentified procedure, the anesthesia circuit detached from the ventilator.Reportedly, the patient was unable to be ventilated by the physician when this occurred.After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient, product, or procedural information related to this incident to the manufacturer.It is unknown what was done after noticing the reported detachment.No impact to the patient, the patient's stability, the patient's plan of care, or the procedure was originally reported to the manufacturer.No adverse effect was originally reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that during an unidentified procedure, the anesthesia circuit detached from the ventilator.

• Type of Device: ANESTHSIA CIRCUIT ADULT-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8103213
• MDR Text Key: 129346804
• Report Number: 1417592-2018-00128
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10888277798694
• UDI-Public: 10888277798694
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJAAF6718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other