MAUDE Adverse Event Report: AMICO CORPORATION AMICO MEDICAL CART; CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Model Number HMFPELL35UU38LR850

Device Problems Material Discolored (1170); Overheating of Device (1437); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During routine use the unit would stop functioning.During inspection of the unit by certified biomedical technician, it was found the power cable between the battery and the power converter/charger burned and carbonized.Fda safety report id# (b)(4).

• Brand Name: AMICO MEDICAL CART
• Type of Device: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• Manufacturer (Section D): AMICO CORPORATION; new york NY
• MDR Report Key: 15915428
• MDR Text Key: 304881442
• Report Number: MW5113600
• Device Sequence Number: 1
• Product Code: BZN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2022

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 Operator: Health Professional
• Device Model Number: HMFPELL35UU38LR850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1