MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS MRI; ANESTHESIA UNITS

Catalog Number 8607300

Device Problems Battery Problem (2885); Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported there was a low battery message and the unit switched modes and rebooted during a case.There was no injury reported.

Manufacturer Narrative

The hospital's biomed is performing the service and repair activities on his own.After having contacted the dräger service hotline for assistance, he replaced the device's mainboard as per recommendation.The replaced pcb was reportedly shipped to dräger but obviously got lost on the way as it was not yet received so far after certain weeks.According to the description of event the machine posted a "battery low" alarm before it rebooted.The most likely explanation would be a situation where a short-term loss of ac power happens when the internal batteries are depleted.The biomed was able to determine that, with the original main pcb installed, the device runs w/o problems on mains supply but batteries were not charged.This can have different root causes i.E.The dedicated fuse may have been blown, a contact problem might have occurred etc.Due to the fact that the original board was not available for investigation, the exact root cause cannot be determined.The respective field failure rate however is inconspicuous.The device is back in use after the repair exchange and did not exhibit any further problems since then.Dräger finally concludes that the workstation responded as designed upon a deviation of unknown origin - a short-term drop in the supply voltage for the main pcb must have occurred, a reboot was initiated to overcome the error condition and the user was alerted to that by means of a corresponding alarm.Reportedly, the device restored operation with previous settings and, no patient consequences have occurred.

Event Description

Please refer to initial mfr.Report #9611500-2018-00282.

• Brand Name: FABIUS MRI
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7832133
• MDR Text Key: 118875051
• Report Number: 9611500-2018-00282
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1