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

Catalog Number 8606500

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device stopped automatic ventilation during use on a patient.There was no injury reported.

Manufacturer Narrative

The device was evaluated on-site in follow-up of the event whereby no deviations from specification could be determined.The device passed all tests and was returned to use without further problems being reported since then.A log file analysis for the period in question was provided by the manufacturer.The records therein demonstrate that the power-on self-test was provided in the morning of the date of event and was passed without functional restrictions.The particular procedure suffered from a large leak in the patient circuit outside the device - a difference of up to 4 l/min between expiratory and inspiratory flow was measured.The device posted appropriate alarms like apnea and mv low repeatedly.The user switched forth and back between man/spont and volume mode, but this stayed without any notable improvement.About 30 minutes after start of automatic ventilation the device was powered-off.Dräger finally concludes that there is no issue with the device which would require repair or correction.The ventilation episode was heavily disturbed by a leakage in the patient circuit upon which the device responded with appropriate alarming.

Event Description

It was reported that the device stopped automatic ventilation during use on a patient.There was no injury reported.

• 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: 10733503
• MDR Text Key: 213024731
• Report Number: 9611500-2020-00377
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1