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

Catalog Number 8606500

Device Problems Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

The responsible dräger service engineer could confirm the reported issue during on-site checking and trace it back to the ventilator motor.The entire motor assembly was replaced, consequently.Also the evaluation of the log file confirms an issue with the ventilator (motor) on the date of event.In case the apollo shuts down automatic ventilation, the device will generate an audible alarm and a visible alarm message "ventilator fail" will be displayed.In this case automatic ventilation is not possible.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The motor asm has brushes, ball bearing, commutator disk and a spindle which are affected from aging caused by wearing.The kollmorgen motor asm, that was installed in the objected device, has been designed for a durability of >10 years (5 hrs/day, 5 days/week, 52 weeks/year, 13000 hours).The involved motor is approx.14 years old and with the 15598 hours logged, the device reached 120% of the estimated working hours.The replacement of the affected motor asm by the dräger service engineer has already solved the problem, no patient consequences have reportedly occurred.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 during a case that the ventilator stopped working.There was no patient injury reported.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGER MEDICAL DEUTSCHLAND GMBH; moislinger allee 53-55; lübeck D-235 42; GM D-23542
• MDR Report Key: 9254511
• MDR Text Key: 177245406
• Report Number: 9611500-2019-00357
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/03/2019,09/23/2019

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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