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

Catalog Number 8605310

Device Problems Decrease in Pressure (1490); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

Vent fail reported.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text: on-going.

Manufacturer Narrative

The dispatched fse could not duplicate the reported ventilator failure; the machine passed all tests and was returned to use without further problems reported to date.The log file was analyzed by the manufacturer.Unfortunately, the user log section which covers alarms and interactions with the device was partly overwritten already.As per report, the suspicious device behavior was observed around 9am - the user log starts at 12:53pm with stable ventilation parameter.The other log section provides evidence that a large external leakage had come into effect at the time of event; minute volume leaks of up to 6.7 l/min have been recorded.Since no persisting error condition could be found with the device and no vent fail was recorded in the error log it is seen likely that the user-perceived failure to ventilate was indeed related to the presence of a large leak in the patient circuit leading to a loss of volume, pressure and fresh gas while the ventilator has delivered as set.Since the alarm functionality was tested in follow-up of the event with no findings, it can be expected that the device has posted appropriate alarms during the course of event.All alarms, possible causes and remedies are described in the instructions for use.Finally, it is concluded after completing the investigation that the case does indeed not meet reporting criteria.

Event Description

Vent fail reported.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17349537
• MDR Text Key: 319383509
• Report Number: 9611500-2023-00266
• 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,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8605310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2007
• 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