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 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the display of the device froze during ventilation.The user reportedly turned the device off and on, but the device could not start anymore.There was no patient injury reported.

Manufacturer Narrative

After the case in question, a fse replaced the pcb which controls display and user interface.The replaced pcb was analyzed in the manufacturer¿s lab and no indications for a malfunction were found.A long-time run was performed and a new logfile was taken and no errors or failures were found either.Therefore, the exact root cause for the reported symptom could not be determined.In case of a frozen monitor integrated monitoring and selection of parameters/ modes is not possible any more.During automatic ventilation an automatic shutdown of the ventilation mode and switch to the man/ spont mode will be done.An alarm will be given via the secondary piezo signal generator of the power supply.

Event Description

Please refer to the initial-report.

• 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: 9590474
• MDR Text Key: 175355822
• Report Number: 9611500-2020-00009
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)151116(93)8606500-59
• Combination Product (y/n): N
• PMA/PMN Number: K045607
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• 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: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1