MAUDE Adverse Event Report: GE HEALTHCARE VERSAMED; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number IVENT 201

Device Problems Break (1069); Device Emits Odor (1425); Failure to Power Up (1476); Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2018

Event Type  malfunction  

Event Description

C-arm failure: had to turn off multiple times and let sit for a few minutes before turning on.Error messages are "precharger voltage error, voltage error, charger failure, and also filament failure.We could smell a burning smell from machine.Patient was not harmed at all and the procedure was finished.The machine was sent to ge for factory repair.Ge repaired the unit and returned it.See manufacturer findings for details of manufacturer response for ventilator, versamed (per site reporter).The product was sent to g.E.From the service report: g.E.Verified error messages: codes 346 and 345 which are motor failure codes.Found that the screen did not turn on when powered up due to wire broken on the inverter cable.Found that the o2 sensor was bad due to low voltage.O2sensor-old: 7.3 mv; new- 12.5 mv.Action taken: to correct the problem error codes 346 and 345, the pneumatic module was replaced.To correct the problem of the broken wire on the inverter cable, the inverter cable was replaced.The o2 sensor was replaced.All performance testing passed.Passed all required tests and is ready for use.

Event Description

C-arm failure: had to turn off multiple times and let sit for a few minutes before turning on.Error messages are "precharger voltage error, voltage error, charger failure, and also filament failure.We could smell a burning smell from machine.Patient was not harmed at all and the procedure was finished.The machine was sent to ge for factory repair.Ge repaired the unit and returned it.See manufacturer findings for details of the repair.Manufacturer response for ventilator, versamed (per site reporter).The product was sent to g.E.From the service report: g.E.Verified error messages: codes 346 and 345 which are motor failure codes.Found that the screen did not turn on when powered up due to wire broken on the inverter cable.Found that the o2 sensor was bad due to low voltage.O2sensor-old: 7.3 mv; new- 12.5 mv.Action taken: to correct the problem error codes 346 and 345, the pneumatic module was replaced.To correct the problem of the broken wire on the inverter cable, the inverter cable was replaced.The o2 sensor was replaced.All performance testing passed.Passed all required tests and is ready for use.

• Brand Name: VERSAMED
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): GE HEALTHCARE; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 8467257
• MDR Text Key: 140455431
• Report Number: 8467257
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IVENT 201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29200 DA