MAUDE Adverse Event Report: CAREMED SUPPLY, INC. ULTRA-CAIR BLOWER; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number TD60-1

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

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

Event Date 10/10/2020

Event Type  malfunction  

Event Description

Describe the unusual occurrence: the control unit for the mattress sparked and caused a burn to the sheet of the pt's bed.No one was hurt but the pt and a family member both witnessed the incident.I asked the facility for the pt's family member's info but was told that they didn't have it.Burn is about the size of a dime.No exposed wires that they could see.The room lost power 30 minutes prior and then the cu sparked.The facility has already moved the pt to a different room and mattress and refused pick up of the mattress until they hear back from someone on their end.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ULTRA-CAIR BLOWER
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED SUPPLY, INC.
• MDR Report Key: 17525409
• MDR Text Key: 321038419
• Report Number: MW5132350
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2020

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?: No
• Device Model Number: TD60-1
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1