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

Catalog Number	HCS7000
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per report, "issue is unit is not powering on and customer is looking for a replacement.The vacuum pump is used in operating rooms of our surgery center.The unit was intermittently working until it finally stopped working.The defective unit was taken out of service and an alternate unit was used in its place.No issue with patient.However, we have had to purchase a brand new unit because the process to get the unit repaired is very slow, time consuming and inefficient." there were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Event or Problem Description
Per report, "issue is unit is not powering on and customer is looking for a replacement.".

• Brand Name: MEDLINE VAC-ASSIST SUCTION ASPIRATOR
• Common Device Name: ASPIRATOR,SUCTION,VAC-ASSIST
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25215992
• Report Number: 1417592-2026-01356
• Device Sequence Number: 15897176
• Product Code: JCX
• UDI-Device Identifier: 40080196769293
• UDI-Public: 40080196769293
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 03/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Patient Sex: Unknown