MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. AHP300

Model Number	AHP300Y
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have become aware of an incident involving the ahp300-y.The ventilator was placed on the patient with no problem.The ahp300 sounded a critical battery alarm which they then plugged the unit into ac (115 volt) on the ambulance.The alarm kept sounding but the unit kept performing.The paramedic didn't think the ahp300 would continue running after being removed from the ac line in the ambulance, so the hospital was notified to have a portable ventilator ready for transfer when they arrived.The device has been sent back to the manufacturer and is currently being investigated.
Event or Problem Description
The paramedics were at the hospital to do a transport, they placed the patient on the ahp300 with no problem.When they got the patient into the ambulance and started driving the ahp300 sounded a critical battery alarm.When the alarm sounded, they plugged the unit into ac (115 volt) on the ambulance and the alarm kept sounding but the unit kept performing.They had notified the hospital they were enroute and to have a portable ventilator ready for transfer when they arrived as she didn't think the ahp300 would continue running after being removed from the ac line in the ambulance.

• Brand Name: AHP300
• Common Device Name: AHP300
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis 63110 ; 3147712400
• MDR Report Key: 14323798
• Report Number: 1924066-2022-00002
• Device Sequence Number: 20138525
• Product Code: BTL
• UDI-Device Identifier: 00026072000175
• UDI-Public: 00026072000175
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: AHP300Y
• Device Catalogue Number: AHP300-Y
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2016
• 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