MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCT INC. ALLIED; EPV100

Model Number	EPV100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This was a 8 year old unit that was returned and the 5 year maintenance was performed.It met all specifications after the maintenace was completed.
Event or Problem Description
Will not turn on with the batteries installed.

• Brand Name: ALLIED
• Common Device Name: EPV100
• 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 63100
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis, MO 63110 ; 3147714200
• MDR Report Key: 20273574
• Report Number: 1924066-2024-00046
• Device Sequence Number: 12572850
• Product Code: BTL
• UDI-Device Identifier: 00026072000250
• UDI-Public: (01)00026072000250
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K072214
• 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: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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
• Device Model Number: EPV100
• Device Catalogue Number: EPV100
• Device Lot Number: NO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2020
• 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
• Patient Sex: Unknown