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

Catalog Number 8606000

Device Problems Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

It was reported that the device shut down during use.The case was completed with a replacement device.There was no injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

The device was inspected by an engineer of the local s&s organization.It was found that the device couldn't be supplied with electrical energy - the device's power supply did not work and, the internal battery was depleted.The power supply was replaced, consequently.The workstation was subject to intensive testing afterwards and found fully compliant to specification.The course of event could not be reconstructed in detail since it was not possible to secure a log file.Based on the findings made in follow-up of the event it is plausible that the power supply failed during use and the device ran on battery until the latter was depleted.The device is designed to post an alarm if mains power gets lost for any reason and continues operation on battery supply.The residual battery capacity is being displayed; with a fully charged battery the minimum runtime is 30 minutes.Battery depletion alarms will be posted if the residual capacity underruns 20% and 10%, respectively.The alarm functions have been tested after repair exchange of the power supply.No deviations were found and thus, it is concluded that appropriate alarms have been posted during the course of event.The device is almost 13 years old; the malfunction of a single electronic component after such long time of use can be considered acceptable.Appropriate risk mitigation measures are in place - the device posts corresponding alarms to indicate the loss of mains power supply; the device continues operation on battery which leaves room enough for the users to react.Finally, manual ventilation with the built-in breathing bag remains possible even in switch-off state.Dräger concludes that use error was at least a contributing factor in the event.

Event Description

It was reported that the device shut down during use.The case was completed with a replacement device.There was no injury reported.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 15291485
• MDR Text Key: 303250038
• Report Number: 9611500-2022-00217
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NA.; NA.