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

Catalog Number 8606500

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

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that there was a ventilator failure message displayed during a case.The patient was bagged to finish the case.No patient injury reported.

Event Description

It was reported that there was a ventilator failure message displayed during a case.The patient was bagged to finish the case.No patient injury reported.

Manufacturer Narrative

Upon checking the log files the hospital's biomed could confirm the observed shut-down of automatic ventilation.The engineer identified problems with the ventilator motor and ordered a motor assembly for replacement, consequently.Evaluation of the returned original motor performed in the manufacturer's lab revealed that wear-and-tear related abrasion of the collector disc had resulted in development of positions where the motor does not provide mechanic power due to contact interrupts to the carbon brushes; speed fluctuations will be the consequence.Since the motor speed is being monitored continuously, the speed fluctuations result in a deviation between measured and expected piston position.To prevent from potentialy hazardous output and/or 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.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component after almost 15 years of use; no patient consequences have been reported.The repair exchange will fully solve 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.

• 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: 11900004
• MDR Text Key: 256167036
• Report Number: 9611500-2021-00229
• 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: 07/13/2021

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 Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1