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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

During internal review, it was noticed that this case was not reported by the manufacturer.It was reported that a vent fail occured during use.There was no patient injury reported.

Manufacturer Narrative

Based on the performed log file analysis, a sporadic failure of the inspiratory pressure sensor of the pcb vgc (ventilation and gas controller) was detected.Consequently, an autonomous shutdown to safety mode was initiated.The corresponding ventilator fail alarm was displayed and an acoustic alarm given.Manual ventilation as well as monitoring function remained possible.Dräger finally concludes that the device reacted as specified upon a sporadic failure of the inspiratory pressure sensor.On-site, in follow-up of the event, the dispatched draeger technician has already replaced the pcb vgc as a precautionary measure.The device was successfully tested afterwards and was returned to use without further problems reported.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 ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 15010898
• MDR Text Key: 295888075
• Report Number: 9611500-2022-00170
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/19/2022,07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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