MAUDE Adverse Event Report: ALLIED MEDICAL LLC EPV200

Model Number EPV200

Device Problem Circuit Failure (1089)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/01/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Received the unit and it is still under investigation.

• Brand Name: EPV200
• Type of Device: EPV200
• Manufacturer (Section D): ALLIED MEDICAL LLC; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis, MO 63146 ; 3147712400
• MDR Report Key: 18250824
• MDR Text Key: 330246743
• Report Number: 1924066-2023-00004
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 00026072000267
• UDI-Public: 00026072000267
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPV200
• Device Catalogue Number: EPV200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention