MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS INC ALLIED; EPV100

Model Number	EPV100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Battery continues to overheat.
Additional Manufacturer Narrative
The unit was returned for repair and was recalibrated and tested.It met all specifications after the calibration was completed.

• Brand Name: ALLIED
• Common Device Name: EPV100
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS 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: 20273389
• Report Number: 1924066-2024-00049
• Device Sequence Number: 3505362
• 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
• 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: 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: 12/05/2022
• 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