MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIR IV; BED, FLOTATION THERAPY, POWERED

Model Number KINAIR IV

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem No Information (3190)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

Nurse smelled an electrical/burning odor coming from a bed the patient was in; appears to be a possible motor problem.

• Brand Name: KINAIR IV
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore road suite 308; san antonio TX 78247
• MDR Report Key: 4780450
• MDR Text Key: 5877827
• Report Number: 4780450
• Device Sequence Number: 1
• Product Code: IOQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/13/2015

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: Invalid Data
• Device Model Number: KINAIR IV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2015
• Patient Sequence Number: 1
• Treatment: THIS WAS A PATIENT BED THAT THE PATIENT WAS IN AT; THE TIME OF THE EVENT.