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

Catalog Number 8606000

Device Problems Gas Output Problem (1266); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The result will be forwarded in a follow up report.

Event Description

It was reported that during preoxygenation (apl valve on spontaneous, o2 flow first 4l, then increase to 9l, as the patient found it difficult to breathe with the mask), the bypass measurement indicated both inspiratory and expiratory room air values.However, the mask was not very tight as the patient was restless.Sufentanil was given and the patient became more restless, so propofol was given and relaxation.Manual ventilation with the ventilator was not possible.The spo2 decreased rapidly after hypnotics were given.Despite 12.1l/min o2 flow on the display of the ventilator, the alarm message "fresh gas flow low" was generated.The o2 wall connection was regularly engaged.Even after opening the air flow to >10l/min, manual ventilation with the ventilator was still not possible.After switching to an ambu bag, ventilation was possible without any problems and the patient quickly saturated again." additional description: "the apl valve was at values around 20 mbar, a change brought nothing.The ventilation was set to "manual".The bag was full, but a squeeze did not lead to an air emission at the ventilation filter, so that ventilation was impossible.In the pressure curve on the monitor there was a zero line, so no reaction to any activity.Co2 curve also at "zero".The hoses were inserted correctly.The wall connections were also checked.Switching the device on/off did not help either.The error message included "fresh gas flow low", "ventilation error".

Manufacturer Narrative

The electronic log file was available for investigation.The reported fresh gas deficit and ventilator failure could be confirmed by means of the information stored therein.On the reported date of event the fabius detected a negative pressure within the ventilator cylinder.This usually indicates a fresh gas deficit.In contrast to that, the user reported that the breathing bag was completely filled.According to specification, the automatic ventilation was temporarily stopped and alerted with "ventilator failure" in case a negative pressure is detected.An obstruction at the co2 absorber was seen as potential root cause but this could not be confirmed with the available information.Hence it was requested to perform further tests with the device but that was impossible since the customer has already put the affected fabius out of service respectively replaced it.Finally the reported event could be confirmed but the exact root cause could not be determined.

Event Description

It was reported that during preoxygenation (apl valve on spontaneous, o2 flow first 4l, then increase to 9l, as the patient found it difficult to breathe with the mask), the bypass measurement indicated both inspiratory and expiratory room air values.However, the mask was not very tight as the patient was restless.Sufentanil was given and the patient became more restless, so propofol was given and relaxation.Manual ventilation with the ventilator was not possible.The spo2 decreased rapidly after hypnotics were given.Despite 12.1l/min o2 flow on the display of the ventilator, the alarm message "fresh gas flow low" was generated.The o2 wall connection was regularly engaged.Even after opening the air flow to >10l/min, manual ventilation with the ventilator was still not possible.After switching to an ambu bag, ventilation was possible without any problems and the patient quickly saturated again." additional description: "the apl valve was at values around 20 mbar, a change brought nothing.The ventilation was set to "manual".The bag was full, but a squeeze did not lead to an air emission at the ventilation filter, so that ventilation was impossible.In the pressure curve on the monitor there was a zero line, so no reaction to any activity.Co2 curve also at "zero".The hoses were inserted correctly.The wall connections were also checked.Switching the device on/off did not help either.The error message included "fresh gas flow low", "ventilation error".

• 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: 13340787
• MDR Text Key: 287269911
• Report Number: 9611500-2022-00019
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/15/2022

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 Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2006
• 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): Other