MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP CONCHASMART; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Lot Number 74F2202223

Device Problem Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2022

Event Type  malfunction  

Event Description

Melted circuit limb.Situation: ventilator circuit melted.Background: rt called to bedside for low minute ventilation alarm.Noted to have large leak based on waveforms.Assessed patient ett and circuit for possible leaks.Two areas noted on vent circuit to have melted from heated wire.Assessment: ventilator immediately changed, and circuit saved for further inspection.Recommendation: closely monitor circuit for possible defective areas.Manufacturer response for adult concha smart breathing circuit w/dual heated limbs, (brand not provided) (per site reporter) rt lead has been in email conversation with medline representative.

• Brand Name: CONCHASMART
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; one medline place; mundelein IL 60060
• MDR Report Key: 15679428
• MDR Text Key: 302493677
• Report Number: 15679428
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 74F2202223
• 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: 10/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA
• Patient Sex: Male
• Patient Weight: 12 KG