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

Model Number	AHP300
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit has not been returned for investigation.
Event or Problem Description
The unit failed while on a patient.It had a battery less than a year old in it and i have put a new battery in it sense.It shows a full battery until you turn it on.Then it throws the critical battery alarm and will not function.Definitely not a battery issue.

• Brand Name: ALLIED
• Common Device Name: AHP300
• 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: 21590094
• Report Number: 1924066-2025-00045
• Device Sequence Number: 21091235
• Product Code: BTL
• UDI-Device Identifier: 00026072000014
• UDI-Public: (01)00026072000014
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: AHP300
• Device Catalogue Number: AHP300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown