MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ASPIRATOR,SUCTION,VAC-ASSIST

Catalog Number	HCS7000
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Codes	Airway Obstruction (1699); Dyspnea (1816); Discomfort (2330)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "a resident was in need of emergency suction and we pulled three canisters to use and all three would not suction".The resident was sent to the er and admitted to the hospital.The facility stated the resident passed away but that the cause of death was not because of the canisters.The facility stated the resident was sick already and that "he would have been more comfortable with the suctioning but we were unable to and had to call the squad because of the suctioning was not working and he was unable to take breathes because the airway needed suctioned".A definitive cause of death has not been provided to the manufacturer.Although the facility only mentioned the canisters during follow up on the reported incident, they provided the manufacturer with aspirator samples.Multiple good faith follow up attempts were made to clarify if the aspirators were involved in the reported incident, however, the facility was unable to be reached and involvement of the aspirator samples were unable to be confirmed.Because the contact could not confirm if the aspirator was involved or not, in an abundance of caution, this report is being submitted.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
According to the facility, "a resident was in need of emergency suction and we pulled three canisters to use and all three would not suction".
Additional Manufacturer Narrative
Update to h6.After further investigation, it has been determined that the investigation involved testing of the actual/suspected device, a trend analysis, and an analysis of production records.The investigation identified a of dust or dirt problem, an operational problem, a wear problem, and a deformation problem.The cause has been traced to the user.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: ASPIRATOR,SUCTION,VAC-ASSIST
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24080151
• Report Number: 1417592-2026-00045
• Device Sequence Number: 13190134
• Product Code: JCX
• UDI-Device Identifier: 40080196769293
• UDI-Public: 40080196769293
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HCS7000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male