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

Catalog Number 8606500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cyanosis (1798)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient became desaturated immediately following intubation.The patient's saturation was about 60% and the patient became blueish.There was no patient injury reported.

Manufacturer Narrative

Based on the logfile analysis, no indications for a device malfunction were found.Neither during nor before or after the reported event.The logfile show that the case was started at 6:08am using man/spont and continued in volume mode from 6:15am.The following ventilation was unremarkable and stable while the measured inspiratory o2 was >90% permanently.At 7:23am, the user switched over to volume af mode.In the following, while ventilation was still stable, the inspiratory o2 decreased to 45% around 8:00am and remained on this level for the remainder of the case.From 11:57am on, ventilation was continued using pressure support mode.At 12:33pm, the mode was changed to man/spont before the unit was placed in standby at 12:38pm.In general, the logfile analysis revealed that the ventilator as well as gas dosage were fully functional during the whole case.Patient gas measurement was operational, and the measured values were plausible.Finally, the reported symptom could not be understood from the logfile records.A dräger technician evaluated the device in follow-up to the event and no device error was found either.After testing, the device was returned to use with no further problems reported.

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: 10054769
• MDR Text Key: 191576980
• Report Number: 9611500-2020-00158
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening