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

Model Number HMFPELL35UU38LR850

Device Problems Ambient Temperature Problem (2878); 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: MEDICAL CART
• Type of Device: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• Manufacturer (Section D): AMICO CORPORATION; 600 prime place; hauppauge NY 11788
• MDR Report Key: 15915619
• MDR Text Key: 304888628
• Report Number: MW5113608
• 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

• Date FDA Received: 12/02/2022
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1