MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCT INC. AHP300 VENTILATOR

Model Number	AHP300
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the user, ems transport of vent dependent patient.Attempted to use the ems transport ventilator, the internal battery for the ventilators do not hold a charge.
Additional Manufacturer Narrative
Device not available for investigation.There initial report was contacted but could not provide anymore information than what was on the fda report (b)(4).Multiple attemps to contact the contact person has been made.

• Brand Name: AHP300 VENTILATOR
• Common Device Name: AHP300 VENTILATOR
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCT INC.; 1720 sublette avenue; st. louis MO 63110
• Manufacturer (Section G): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave; saint louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; saint louis, MO 63110 ; 3147712400
• MDR Report Key: 15748414
• Report Number: 1924066-2022-00005
• Device Sequence Number: 6241629
• Product Code: BTL
• UDI-Device Identifier: 00026072000175
• UDI-Public: 00026072000175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132021
• 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): 10/28/2022

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: AHP300
• Device Catalogue Number: AHP300
• 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: 09/29/2022
• Initial Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 76 KG