MAUDE Adverse Event Report: GE MEDICAL SYSTEMS AESPIRE; GAS-MACHINE, ANESTHESIA

Model Number AESPIRE

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

Dr was moving the anesthesia ventilator out of a storage area into a room in radiology.There is at least one threshold on the floor that the ventilator is rolled over in order to get it into the room.Once over the threshold, the vent was moved into position inside the room.At this time, a caster fell off.The ventilator leaned, but it did not fall to the floor.The dr reported he was able to stabilize it until unit was repaired.

• Brand Name: AESPIRE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE MEDICAL SYSTEMS; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 3826637
• MDR Text Key: 4447598
• Report Number: 3826637
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/20/2014

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: Physician
• Device Model Number: AESPIRE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2014
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WHEN I SAY "OPERATING", I MEAN THE; ANESTHESIOLOGIST WAS PUSHING THE DEVICE INTO A; ROOM. IT WASN'T CONNECTED TO A PATIENT.