MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA PRIMUS IE; ANESTHESIA UNITS

Catalog Number 8607500

Device Problems Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.We will provide results within a separate follow-up-report.

Event Description

It was reported that during a surgical case there was a shooting flame within the mouth of the patient.The device was turned off immediately.O2 had been decreased to less than 20%.

Manufacturer Narrative

The anesthesia machine was available for investigation.There was no specific device malfunction reported.The reported event could be reconstructed by means of the information stored in the electronic log file.The case in question was started at 10:36am using manual ventilation.On 10:44am the user switched to automatic ventilation (pressure mode).At this time the device measured 97% inspired and 91% expired o2.In the following ventilation was unremarkable.The o2 concentration decreased until it reached 36%/30% (insp./exp.).At the end of the case it increased again to 100%/98% until 11:48, when the case was completed by switching the device to standby.The device was subject to a long-term test run for several days with various ventilation patterns and o2 settings and operated properly at any time.No deviation could be found.The user reported that 20 was decreased to less than 20%.This could not be understood since the device does not allow adjustment of less than 21%.In addition the lowes reading vor inspired o2 concentration was 36%.The investigation has not revealed a device failure.After a final test the machine will be returned to the customer.

Event Description

Please refer to the initial-report.

• Brand Name: PRIMUS IE
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• Manufacturer (Section G): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; luebeck, 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 7654761
• MDR Text Key: 112877083
• Report Number: 9611500-2018-00222
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8607500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• 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): Other