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

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that a deflagration occurred in the oral cavity of a patient during an operation in connection with electrosurgery and that the patient suffered burns.

Manufacturer Narrative

The electronic device logfile was available for the investigation.No product malfunction was reported by the user.Based on the logfile analysis, no indications for a device malfunction were found either.The case in question was started at 10:06am in man/spont mode and continued from 10:12am in volume mode.In the following, the device alarmed volume not attained and mv low.At 10:17am, the user switched to man/spont for a few minutes before therapy was continued in volume mode (10:22am).During the following automatic ventilation, the ventilator repeatedly went into pressure limitation and alarmed accordingly pressure limitation and volume not attained as well as apnoe.At 10:30am, a significant leakage (0.7 l/min) was detected.Based on the patient gas measurement data, a disconnection has obviously taken place.This may have been the time of the deflagration.At this time, the inspiratory oxygen concentration was approx.85 vol.%.The user temporarily switched to man/spont and then back to volume mode.The following ventilation was initially characterized by high airway pressures (pressure limitation), corresponding alarms were issued - as before.Ventilation stabilized from around 10:47am and remained normal until the switch to standby at 11:14am.Dräger finally concludes that most likely, the deflagration was caused by a tube leak - possibly due to damage during the surgical procedure - and the resulting increased oxygen concentration in the operating area with the simultaneous use of electrosurgical devices.Finally, a device malfunction as root cause for the reported deflagration could be excluded based on the performed investigation.

Event Description

It was reported that a deflagration occurred in the oral cavity of a patient during an operation in connection with electrosurgery and that the patient suffered burns.

• Brand Name: PRIMUS
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18805584
• MDR Text Key: 336506013
• Report Number: 9611500-2024-00086
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2009
• 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
• Patient Outcome(s): Required Intervention