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

Catalog Number 8607500

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

The investigation was started but has not yet been concluded.The investigation result will be reported in a follow up-report.

Event Description

It was reported that a service technician of a third party service provider connected a backup o2-cylinder to the primus anesthesia workstation.While opening the cylinder valve, there was an ignition at the external pressure regulator that was mounted on that valve.The service technician suffered burns injuries which required emergency treatment in a hospital.(b)(4).

Manufacturer Narrative

The reported information including photos of the affected pressure reducer, bottle and bottle valve and also the information obtained during the onsite meeting provided basis for our evaluation of this case.The pressure reducer shows clear burn-out tracks in the upper region of the secondary pressure housing and also in the region of the pressure relief valve.According to its serial number the affected pressure reducer was manufactured in february 2016 with an o2 din 477 high-pressure port.Based on the photos and the observations during the onsite visit the pressure reducer was modified after delivery.The high-pressure port deviates from the specified delivery state.Visible damages to the hexagon provide additional proof for this unauthorized modification.Apart from the different port coding and the plastic hand wheel there is also no inlet filter visible.The instructions for use of the pressure reducer [ifu 9037337, edition 9, from 2015-04] provide the following waring: ¿risk of malfunctions and of patient injury.Modifications may damage the device or impair the proper functioning of the device and lead to patient injury.Do not modify or misuse the pressure reducer.Do not remove the inlet filter.¿ consequently the installation of another high pressure port is an unauthorized modification, which is a clear user error.

• Brand Name: PRIMUS IE
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 6278903
• MDR Text Key: 65791184
• Report Number: 9611500-2017-00023
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675224747
• UDI-Public: (01)04048675224747(11)161104(17)170331(93)8607500-46
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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): Disability