MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODCUTS INC ALLIED HELATHCARE PRODUCTS INC.; EPV200

Model Number	EPV200
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was connected to the epv200 went into desaturation and started having prblems with breathing.The staff had to call a rapid response team and a medical emergency code.During this incident it did not make a single sound.
Additional Manufacturer Narrative
Received the unit and it is still under investigation.
Additional Manufacturer Narrative
Udi related data quality updates only.Several updates have been made to this report.The full udi has been entered, along with the 5 10(k).The information entered in this report and that of the gudid that did not match are the brand name and the manufacturer name.The reasoning behind this difference is that we were considered allied healthcare products inc.When the suspect medical devices were manufactured as well as when the malfunction occurred.The medwatch was submitted after we became allied medical llc.The reason behind this is allied healthcare products inc.Declared bankruptcy and its assets were sold on (b)(6) 2023, which was when allied medical llc was created.Please let me know if you have any questions.
Event or Problem Description
The patient was connected to the epv200 went into desaturation and started having problems with breathing.The staff has to call a rapid response team and a medical emergency code.During this incident it did not make a single sound.

• Brand Name: ALLIED HELATHCARE PRODUCTS INC.
• Common Device Name: EPV200
• Manufacturer (Section D): ALLIED HEALTHCARE PRODCUTS INC; 1720 sublette ave; st. louis MO 63110
• Manufacturer (Section G): ALLIED HEALTHCARE PRODUCTS INC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 18250824
• Report Number: 1924066-2023-00004
• Device Sequence Number: 6572084
• Product Code: BTL
• UDI-Device Identifier: 00026072000267
• UDI-Public: (01)00026072000267(21)20131003003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: EPV200
• Device Catalogue Number: EPV200
• Device Lot Number: NO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2012
• 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: Required Intervention
• Patient Sex: Unknown