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

Catalog Number 8606500

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported a vent fail occurred during a case; there was no injury to the patient.

Event Description

Please refer to initial mfr.Report #9611500-2018-00258.

Manufacturer Narrative

A draeger fse could confirm the issue upon on-site evaluation of the electronic log file and has replaced the ventilator motor.The workstation passed all consecutive tests and is now back in use again.The replaced motor was handed over to the manufacturer for evaluation.Evaluation of the motor in the manufacturer's lab revealed that there were several positions where the motor did not provide mechanic power due to a mechanically abraded collector disc.The motor speed is being monitored continuously and, the speed fluctuations result in a deviation between measured and expected ventilator piston position.To prevent from damages 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 which - in the particular case, enabled the user to finish the surgical procedure.Drager finally concludes that the device responded as specified upon the malfunction of a single wear-and-tear component; no patient consequences have been reported.The repair exchange of the motor assembly has fully solved the reported problem.Proper function of the entire device was verified by testing after the repair measures.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7788843
• MDR Text Key: 117704725
• Report Number: 9611500-2018-00258
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1