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

Model Number 8606500

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the unit alarmed for a ventilator failure during a case.There was no patient injury reported.

Manufacturer Narrative

The electronic log file and the replaced motor were available for investigation.The reported ventilator failure could be reconstructed by means of the information stored in the log file.During the case in question, the apollo detected a deviation between the measured and the expected position of the ventilator piston.The device reacted in accordance with its implemented safety concept as it interrupted automatic ventilation, switched to man/spont mode and generated a corresponding audible and visible ventilator fail alarm.In such case both manual ventilation and monitoring functions will remain unaffected and available.Hence, the user is able to ventilate the patient manually and monitor relevant information regarding ventilation and gas delivery.Further investigation of the returned ventilator motor revealed an excessive amount of oil on the spindle and the encoder disc of the motor assembly.It was concluded that the oil temporarily disturbed the optical detection of the motor position.The replacement of the motor assembly on-site has already fixed the problem.Within the last three years, no similar cases have been reported to draeger.

Event Description

It was reported that the unit alarmed for a ventilator failure during a case.There was no patient injury 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
• MDR Report Key: 13437839
• MDR Text Key: 287331198
• Report Number: 9611500-2022-00030
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)170720(17)171218(93)8606500-64
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8606500
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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