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

Catalog Number 8606500

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a case at approximately 8:00 am fire was observed at the expiratory port under the apl valve.Additionally, it was observed that the device was not reading vt or pressure on the display prior to the expiratory flow sensor igniting.There was no patient injury reported.The patient was immediately disconnected and manually ventilated.The unit was swapped out and ventilation was not interrupted.

Manufacturer Narrative

The electronic logfile as well as the breathing system in question were available for investigation.Based on the logfile analysis, no indications for a product malfunction as root cause for the reported fire were found.There was no flow sensor malfunction detected during the ventilation.Thus, it could be assumed that the heat wires were still intact when the ignition occurred.However, it was found that the measured values were clearly too low initially and later not longer available.This leads to the assumption that there was a foreign body in the sensor cuvette leading to shading of the measuring wires.Also the sent image material as well as the inspection of the returned components revealed that the flow sensor has been the origin of the inflammation.Based on the found damages, it was concluded that a foreign body had entered the flow sensor from the patient side, as it would have had to move against the flow direction otherwise.However, there were no indications for a possible foreign body found due to the flame exposure.Since no usable residues were found, the type and origin of the foreign flammable material could not be finally determined.During normal operation, the risk of fire due to a flammable breathing gas mixture (oxygen in combination with volatile anesthetics) streaming through the flow sensor is not given.Due to the safety factor inherent in the design and the thus limited ignition energy due to the contributed electrical power, the probability is zero.In the case different flammable substances as e.G.Ethanol or nebulized drugs are present within the flow sensor, especially during the self-cleaning procedure of the flow sensor, an ignition or deflagration cannot be totally excluded.Self-cleaning procedure is only performed after a coldstart of the device during the boot up sequence prior to the power-on self-test.In the case of an ignition, an expansion of the fire beyond the flow sensor itself can be nearly excluded due to the flame-retardant characteristics of the adjacent materials.The instructions for use of the device contains an appropriate warning: to prevent a fire hazard, drugs or other substances based on inflammable solvents, such as alcohol, must not be introduced into the patient system.Adequate ventilation must be ensured if highly inflammable substances are used for disinfection.Additionally, the instructions for use of the device and the spirolog flow sensor informs about adequate reprocessing procedures e.G.For the breathing system components and the flow sensor.It is recommended to reprocess the breathing system components at least weekly for the case bacterial filters are used.The case was considered as single event, there were no similar cases reported within the last three years.

Event Description

During a case at approximately 8:00 am fire was observed at the expiratory port under the apl valve.Additionally, it was observed that the device was not reading vt or pressure on the display prior to the expiratory flow sensor igniting.There was no patient injury reported.The patient was immediately disconnected and manually ventilated.The unit was swapped out and ventilation was not interrupted.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

During a case at approximately 8:00 am fire was observed at the expiratory port under the apl valve.Additionally, it was observed that the device was not reading vt or pressure on the display prior to the expiratory flow sensor igniting.There was no patient injury reported.The patient was immediately disconnected and manually ventilated.The unit was swapped out and ventilation was not interrupted.

• Brand Name: APOLLO
• 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: 12243886
• MDR Text Key: 266010122
• Report Number: 9611500-2021-00323
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2009
• 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.; NA.