MAUDE Adverse Event Report: MEDLINE INDUSTRIAL INC. ANESTHESIA CIRCUIT - LF; ANESTHESIS CIRCUIT

Lot Number 16AB1606

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 03/07/2016

Event Type  malfunction  

Event Description

Reported to risk that a pt was successfully intubated and the anesthesiologist noticed that the bellows on the anesthesia machine was beginning to lose volume.Was not able to deliver an adequate tidal volume to the pt.The anesthesia machine was checked and could not find a problem so the pt was reintubated but it did not take care of the issue.It was decided to change out the entire anesthesia hose circuit.After that was done anesthesia was able to get the tidal volume back to an adequate level and continued to watch the oxygen saturate and tidal volume until satisfied the issue was resolved.Surgery was performed, completed and the pt was discharged home the same day of surgery.Upon inspection of the anesthesia hoses it was determined there were holes in the tubing.Reorder number is dynjaa10435.Risk has been in contact with representative (b)(4) and received a call from medline quality department (b)(4).The product is to be picked up by (b)(4).

• Brand Name: ANESTHESIA CIRCUIT - LF
• Type of Device: ANESTHESIS CIRCUIT
• Manufacturer (Section D): MEDLINE INDUSTRIAL INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5535745
• MDR Text Key: 41632834
• Report Number: 5535745
• Device Sequence Number: 1
• Product Code: OFP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 16AB1606
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2016
• Distributor Facility Aware Date: 03/07/2016
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR