MAUDE Adverse Event Report: AIR MOVEMENT TECHNOLOGIES, LLC AMT BLOWER; BLOWER, PATIENT POSITIONING MATTRESS

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

While providing skills lab training on patient transfer and positioning equipment the zero lift coach attempted to turn on a portable hovermat mattress blower.The ac switch on the blower assembly broke apart and emitted sparks.The lift coach unplugged the blow form ac power and removed the blower from service and returned to bme for evaluation.

• Brand Name: AMT BLOWER
• Type of Device: BLOWER, PATIENT POSITIONING MATTRESS
• Manufacturer (Section D): AIR MOVEMENT TECHNOLOGIES, LLC; 320 gateway park ave; n. syracuse NY 13212
• MDR Report Key: 3809782
• MDR Text Key: 4523719
• Report Number: 3809782
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/12/2014

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: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1