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

Catalog Number	HCS7000
Medical Device Problem Codes	Corroded (1131); Power Problem (3010); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "will not turn on.".
Additional Manufacturer Narrative
The account reported finding the sample will not turn on.Medline quality received one unit, visually inspected the sample and observed the aspirator was used, attempted to turn the unit on for functional evaluation, and opened the device to check for internal damage and defects; the unit turn on with a low humming sound, no suction pressure was detected, and heavy rust and fluid damage inside the back compartment indicated fluid within the unit.The specific issue of unit not turn on was confirmed as the shaft, eccentric, and the bearing are unable to operate due to fluid damage with received sample.No trends were identified, and the complaint review process has been completed.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: ASPIRATOR,SUCTION,VAC-ASSIST
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897515
• Report Number: 1417592-2026-50861
• Device Sequence Number: 14928550
• Product Code: JCX
• UDI-Device Identifier: 40080196769293
• UDI-Public: 40080196769293
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Catalogue Number: HCS7000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown