MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS INC. AUTOVENT 4000 WITH CPAP; VENTILATOR

Model Number	L760CPAP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The autovent 4000 with cpap was checked prior to putting into service.It was found that the unit failed to deliver a breath but did function once the manual breath button was activated.

• Brand Name: AUTOVENT 4000 WITH CPAP
• Common Device Name: VENTILATOR
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: kevin kroupa ; 1720 sublette ave; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 14626930
• Report Number: 1924066-2022-00004
• Device Sequence Number: 5310232
• Product Code: BTL
• UDI-Device Identifier: 00026072001349
• UDI-Public: 00026072001349
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070120
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

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 Model Number: L760CPAP
• Device Catalogue Number: L760CPAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown