MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCT INC. LSP AUTOVENT 3000

Model Number	AUTO 3000
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was returned for repair, fixed and tested.It met all specifications when completed.
Event or Problem Description
No air delivery.

• Brand Name: LSP AUTOVENT 3000
• Common Device Name: AUTOVENT 3000
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCT INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer (Section G): ALLIED HEALTHCARE PRODUCT INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 20504766
• Report Number: 1924066-2024-00022
• Device Sequence Number: 12857216
• Product Code: BTL
• UDI-Device Identifier: 00026072000816
• UDI-Public: (01)00026072000816
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K932199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/01/2023

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 Model Number: AUTO 3000
• Device Catalogue Number: L461
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown