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

Model Number 8606500

Device Problems Failure to Back-Up (1047); Failure to Deliver (2338); Output Problem (3005); Activation Failure (3270)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation has just started; results will be provided in a follow-up report.On-going.

Event Description

It was reported that the device posted an alarm during a surgical procedure and that it could not be further used.The procedure was continued with a back-up device; no patient consequences have reportedly occurred.

Manufacturer Narrative

The device was subject to an on-site evaluation performed by a dräger service engineer.The reported error condition could not be duplicated but entries were found in the logs for the period in question which were pointing to a problem with the board that controls the gas mixer and the ventilation functions.The board was replaced; the device passed all consecutive tests and could be returned to use.The replaced board was installed into the periphery of a lab device and underwent a test run whereby the error condition could be duplicated.The processor on the particular control board had no access to data stored in an external ram module.If this would occur during a running ventilation episode automatic ventilation is no longer possible; the device performs a safety shut down of automatic ventilation and posts a corresponding alarm.Manual ventilation including gas dosage will be further possible via the built-in breathing bag, monitoring functionalities remain unaffected.The log indicates that - other than reported - the device was not used on a patient when the error condition manifested.The log demonstrates that the workstation could be operated without issues on the day before; it was subject to a leak test afterwards and left in standby.On the next day, the date of event, the device was power-cycled around 5:42pm and the checksum error with the ram occurred right after powering back on.A corresponding alarm was posted.The user power-cycled the device again three minutes later but the error condition persisted and the device could not be used for patient treatment.The ram access error could be traced back to the missing of an internal voltage caused by the malfunction of an individual component onboard the particular pcb.Dräger finally concludes that the device responded as designed upon the particular error condition.The over-all field failure rate of the particular board is within accepted range.

Event Description

It was reported that the device posted an alarm during a surgical procedure and that it could not be further used.The procedure was continued with a back-up device; no patient consequences have reportedly occurred.

• 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: 16774427
• MDR Text Key: 313639456
• Report Number: 9611500-2023-00149
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)200528(17)250203(93)8606500-67
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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 Model Number: 8606500
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• 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