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

Model Number HCS70004RD

Device Problem Improper Flow or Infusion (2954)

Patient Problem Dyspnea (1816)

Event Date 02/01/2023

Event Type  Injury  

Event Description

According to the customer, the nebulizer has stopped "pushing air through it" and the customer is unable to receive his "albuterol treatment".

Manufacturer Narrative

According to the customer, the nebulizer has stopped "pushing air through it" and the customer is unable to receive his "albuterol treatment".The customer reported he is "unable to breathe after walking 10 feet" without his nebulizer because he typically uses it "2-3 times a day".The customer reported he has had to call an ambulance and go the hospital multiple times where they have given him "nebulizer treatments" in order for him to breathe.No additional information is available at this time.Sample requested to be returned.It has been determined that the reported event caused or contributed to serious injury, therefore, 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: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16455681
• MDR Text Key: 310379189
• Report Number: 1417592-2023-00080
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00888277415068
• UDI-Public: 00888277415068
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/28/2023
• 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