MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; COMPRESSOR,NEBULIZER,AEROMIST COMPACT

Catalog Number HCS70004

Device Problem Overheating of Device (1437)

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

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during use, the nebulizer compressor overheated and "melted" the nebulizer tubing.No impact or adverse effect to the patient or the patient's stability was reported to the manufacturer.After an unidentified period of time following this incident, the patient was reportedly admitted to a local hospital.No diagnostic exams/results, medical intervention, or admitting diagnoses were 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 use, the nebulizer compressor overheated and "melted" the nebulizer tubing.After an unidentified period of time, the end-user was reportedly admitted to a local hospital.

• Type of Device: COMPRESSOR,NEBULIZER,AEROMIST COMPACT
• 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: 8560210
• MDR Text Key: 145772132
• Report Number: 1417592-2019-00054
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00884389106870
• UDI-Public: 00884389106870
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HCS70004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 83 YR