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

Catalog Number 8606500

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

Reportedly, the dispatched fse could narrow down the root cause to a problem with the ventilator motor and replaced it.The log files were checked by the manufacturer, and, the reported issue as well as the validity of the on-site analysis can be confirmed.The log file indicates that the procedure in question went stable, and unremarkable for about 15 minutes until a ventilator piston position error occurred.The motor speed is being monitored continuously; speed fluctuations result in a deviation between measured and expected piston position.To prevent from damages to the ventilator unit the system is designed to shut down automatic ventilation, and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.No patient consequences have reportedly occurred.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component which is a wear-and-tear part and has lasted approx.120% of the expected life time.The repair exchange has fully solved the device problem.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment, and thus ,accepted.

Event Description

It was reported that the device alarmed during a case for a ventilator failure.There was no patient injury reported, and the unit was swapped out.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10647123
• MDR Text Key: 210383950
• Report Number: 9611500-2020-00352
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2010
• 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