MAUDE Adverse Event Report: DRAEGER MEDICAL, INC. ANESTHESIA MACHINES

Device Problems Loss of Data (2903); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/15/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, the anesthesia machine in room 14 serial number (b)(4) had a loss of all gas data.The anesthesia machine from room 9 was moved into room 14, with serial number (b)(4) was moved into room with a similar failure per the anesthesia provider.Both logs for these machines were reviewed by draeger tech, mr.(b)(6) and found no errors other than that the full system test had not been performed which we initially believed to be the problem.However, mr.(b)(6) sent the logs off to mr.(b)(6), the draeger technical product manager, for further review.It was identified that the machine from 14 had a pump failure of the m-pgm part number 6872201.Psrs were submitted for both machines.The psr number for the event on (b)(6) is psr-534728 and the number for the event on (b)(6), is psr-551125.On (b)(6) 2017, the anesthesia machine in room 16, serial number (b)(4) had a loss of etco2 and o2 gas analysis.The anesthesia machine was noted out of the room in the middle of a case and replaced with a draeger apollo.The log for this machine was sent to draeger for further review and it was identified that the machine from 16 had a pump failure of the m-pgm part number 6872201.This was after the pump had already been replaced with a new pump.On (b)(6) 2017, the anesthesia machine in room 11, serial number (b)(4) had a loss of etco2 analysis that returned within one minute, but with no annotation that the machine was calibrating or other notification on the screen describing the loss.Due to the anesthesia providers immediate concerns, the machine was moved out of the room and replaced with an apollo for the rest of the cases for that day.The logs were pulled and sent to draeger.No pump failure was noted for this machine and no other explanation was given by draeger.Psrs were submitted for both machines.The psr number for the event on (b)(6) is psr-549685 and the number for the event on (b)(6), is psr-550179.Note: the machines had only been back in the operating room for a total of 4 and 7 days respectively before the next failure.

• Brand Name: ANESTHESIA MACHINES
• Type of Device: ANESTHESIA MACHINES
• Manufacturer (Section D): DRAEGER MEDICAL, INC.
• MDR Report Key: 6556861
• MDR Text Key: 74933992
• Report Number: MW5069658
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention