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

Catalog Number 8606500

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during a case the unit had a heater alarm and then shut down.The patient was manually ventilated and the unit was changed.There was no patient injury reported.

Event Description

Please refer to initial mfr.Report.

Manufacturer Narrative

The dispatched fse has inspected the compact breathing system (cosy) and found contamination at electrical contacts of the cosy heater.The contacts were cleaned and the system was found to be fully compliant to specification again in the consecutive tests and measurements.The log file of the workstation was evaluated by the manufacturer.It could be revealed that the device was powered on at 6:40am on the date of event.During the subsequent power-on self-test (post) the system detected the unavailability of the breathing system heating.The user accepted the restricted device functionality and the post was completed at 6:51am.A surgical procedure was started at 7:36am using man/spont and continued in volume af mode from 7:41am.Just at the beginning a massive circuit leak was detected which led to a fresh gas deficit.Consequently, the device alarmed repeatedly for apnea, volume not attained and fg low or leak.In the following, the user switched repeatedly forth and back between man/spont and volume (af) mode w/o any improvement of situation.At 8:00am the unit was placed into standby, finally.So against to what has been reported to dräger, the device didn¿t shut down autonomously but was disconnected from all supplies and powered down by the user immediately after the unit was placed in standby.This was most likely done due to the restrictions in ventilation the user experienced in consequence to the massive circuit leak and fresh gas deficit.The problem with the cosy heater was a secondary problem since the only effect is that the patient receives breathing gas at room temperature instead of volume heated-up to body temperature.From the viewpoint of gas dosage and ventilation there is no issue with the device that would require repair or correction.

• 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: 8314257
• MDR Text Key: 135703178
• Report Number: 9611500-2019-00043
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1