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

Catalog Number 8606500

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

The electronic apollo device log file was analyzed for the reported date of event (b)(6) 2019.After successful completion of the power-on self-test the case was started at 8:07 am using monitoring mode.At 8:11 am a "minute volume low" and at 8:27 am/8:37 am apnea co2 alarms were given.The recorded patient gas measurement data has shown an increase of inspiratory oxygen up to 99% at 8:20 am.At 8:38 am the unit was placed in standby.The log file analysis revealed no indications for a device malfunction, neither during nor before or after the reported event.The hospital has not alleged any malfunction of the apollo.An examination of the device was requested to insure it is operating according to specification.The device was successfully tested on-site and was cleared to be returned to clinical use.The fire maybe was caused by the use of a 3rd party electro surgical device while operation with o2 from the apollo.The instructions for use of the apollo contains a warning ¿risk of fire- cauterizing close to a source of oxygen can lead to fire.Make sure that all connectors (e.G.Y-piece, breathing hoses including the breathing bag, breathing system, external fresh gas outlet, oxygen therapy, anesthetic gas receiving system) are leak-free so that oxygen leakage cannot endanger the user or the patient.

Event Description

It was reported there was an airway fire during use.The patient sustained 2-3 degree burns on 14-16% of the body.

• 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: 9320355
• MDR Text Key: 166315249
• Report Number: 9611500-2019-00383
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2012
• 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
• Patient Outcome(s): Required Intervention