MAUDE Adverse Event Report: ALLIED HELATHCARE PRODUCTS INC LIFE SUPPORT PRODUCTS; AUTOVENT 4000 CPAP

Model Number	L761CPAP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the unit has a bad leak.
Additional Manufacturer Narrative
Fixed replaced tidal volume adjustment.And broken body.Unit was repaired and returned to the customer.

• Brand Name: LIFE SUPPORT PRODUCTS
• Common Device Name: AUTOVENT 4000 CPAP
• Manufacturer (Section D): ALLIED HELATHCARE PRODUCTS INC; 1720 sublette ave; st. louis MO 63110
• Manufacturer (Section G): ALLIED HEALTHCARE PRODUCTS INC; 1720 sublette ave.; st louis MO 63110
• Manufacturer Contact: wayne karcher ; 1720 sublette ave; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 20348378
• Report Number: 1924066-2024-00029
• Device Sequence Number: 18156427
• Product Code: BTL
• UDI-Device Identifier: 00026072001363
• UDI-Public: (01)00026072001363
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K070636
• 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): 09/11/2024

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: L761CPAP
• Device Catalogue Number: L761CPAP
• Device Lot Number: NO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown