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); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

The instigation is ongoing.We will provide results in a separate follow-up report.

Event Description

It was reported that there was a ventilator failure during use.There was no injury reported.

Manufacturer Narrative

The device was evaluated on-site by a dräger service technician who verified the reported problem and traced it back to an issue with the ventilator motor.The motor was replaced and the workstation was returned to use after having passed all tests w/o further deviations.The replaced motor was analyzed in the manufacturer's lab.It turned out that the motor was not able anymore to start operation without applying mechanical force to the spindle.This indicates that the collector disc is worn which would not be unexpected after almost 12 years of operation with >16.000 hours of runtime logged.The device is designed to shut down automatic ventilation when fluctuations in rotation speed or other deviations occur with the ventilator motor since otherwise significant damages to the ventilator unit may be the result.The shutdown is accompanied by a corresponding alarm to alert the user.Manual ventilation with the built-in breathing bag and the monitoring functions remain available.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

Please refer to initial mfr.Report #9611500-2020-00121.

• 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: 9920291
• MDR Text Key: 186282101
• Report Number: 9611500-2020-00121
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• 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
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1