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

Model Number 8606500

Device Problems Decrease in Pressure (1490); Failure to Deliver (2338); Inaccurate Delivery (2339); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported there was a vent failure while a patient was connected.No patient injury reported.

Manufacturer Narrative

Based on the logfile records the case in question was reconstructed.It started on (b)(6) 2021 at 4:27pm using man/spont.The last power-on self-test (post) has been successfully completed at 4:30am the same morning.The therapy was continued in volume af mode and the following ventilation was at times restricted due to recurring circuit leaks of up to 0.8 l/min.The device issued several alarms, like apnea, mv low and fg low or leak.At 6:15pm the unit was placed in standby.No indications for a technical malfunction in general respectively a ventilator failure in particular could be found.Ventilation was restricted due to leakages in the patient circuit leading to a loss of pressure, volume and fresh gas.Corresponding alarms were posted to inform the user about the situation.The device was successfully tested afterwards and was returned to use without further problems reported.

Event Description

It was reported there was a vent failure while a patient was connected.No patient injury reported.

Event Description

It was reported there was a vent failure while a patient was connected.No patient injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

• 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: 12446580
• MDR Text Key: 271896164
• Report Number: 9611500-2021-00377
• 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,Followup,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8606500
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2015
• 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