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 No Consequences Or Impact To Patient (2199)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided within a separate follow-up report.

Event Description

It was reported during a case the unit posted a ventilator failure alarm.The patient was bagged for the remainder of the case.There was no patient injury reported.

Manufacturer Narrative

Evaluation and assessment of this case was based on log file analysis.The recorded error codes indicate that the supervisor function detected a wrong motor position and forced a shutdown of automatic ventilation.The motor was replaced and the workstation was returned to use after having passed all tests w/o further deviations.The particular device was in operation for nearly 11 years with almost 18.000 hours of runtime logged.The ventilator motor is subject to wear and tear; abrasion at the collector disc is one of the ageing effects that may occur.If there are areas at the circumference of the collector where the electrical contact to the carbon brushes is disrupted due to the abrasion this can have two consequences: a) the motor will not start up from certain positions and b) fluctuations in rotating speed may occur which results in a deviation between calculated and real motor position.Scenario a is the more likely one which will lead to an error during self-test i.E.Will be detected prior to use on a patient.Significant fluctuations in rotation speed i.E.A wrong motor position may cause damages to the ventilator unit and thus, the device is designed to force a shutdown of automatic ventilation when the supervisor function detects these deviations during device operation.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 #9611500-2020-00146.

• 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: 10037599
• MDR Text Key: 190286739
• Report Number: 9611500-2020-00146
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• 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?: Yes
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1