MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; COMPRESSOR, REUS AND DISP NEBULIZER KIT

Model Number HCS70004RD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Dyspnea (1816)

Event Date 06/12/2023

Event Type  Injury  

Event Description

According to the customer the nebulizer wasn't delivering the "albuterol" medication and caused her to have "difficulty breathing".

Manufacturer Narrative

According to the customer the nebulizer wasn't delivering the "albuterol" medication and caused her to have "difficulty breathing".The customer reported she went to the hospital and was given "oxygen and a breathing treatment" because her "oxygen was low".The customer reported she was sent home the same day and is "feeling better".Sample requested to be returned for evaluation.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Type of Device: COMPRESSOR, REUS AND DISP NEBULIZER KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17267745
• MDR Text Key: 318550451
• Report Number: 1417592-2023-00281
• Device Sequence Number: 1
• Product Code: CAF
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HCS70004RD
• Device Catalogue Number: HCS70004RD
• Device Lot Number: 6462203
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2023
• 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