MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ASPIRATOR,SUCTION,W/800CC CANISTER

Catalog Number	HCS7000
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that when the yankauer is attached, pressure is lost.It was reported that "when the aspirator failed then they had to take him to the hospital, according to the mother statement".No additional information was provided.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.
Event or Problem Description
Pressure lost.

• Common Device Name: ASPIRATOR,SUCTION,W/800CC CANISTER
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19605475
• Report Number: 1417592-2024-00683
• Device Sequence Number: 15042807
• Product Code: JCX
• UDI-Device Identifier: 40080196769293
• UDI-Public: 40080196769293
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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 Catalogue Number: HCS7000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 15 YR
• Patient Sex: Unknown