MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA OXYLOG 3000; VENTILATORS, TRANSPORT

Device Problem Component Falling (1105)

Patient Problem Crushing Injury (1797)

Event Date 08/12/2017

Event Type  Injury  

Manufacturer Narrative

The investigaton was started but is not yet concluded.The result will be reported in a follow up-report.

Event Description

It was reported that ambulance was transporting patient, when user noticed that oxylog is still on the floor, so device was connected to equipment holder, while ambulance already moving.Both nurses checked that device was connected right, and could hear click noise, and one of them also checked it is not moving.When turning ambulance in curve in low speed, oxylog suddenly dropped down.It dropped to the bed, but corner of device touched patients forehead, and caused 3cm wound that needed to be stitched.Patient is ok after wound sutured.

Manufacturer Narrative

The affected equipment holder was provided for investigation.No damage could be found during analysis.The equipment holder was found fully functional during testing.As no malfunction could be found and no similar incidents have been reported to dräger in the past, it is likely that the oxylog 3000 has been inserted incorrectly.Thus, it led to an instable fixation that could not hold the device sufficiently when the ambulance was changing its direction.The correct mounting is clearly described in the ifu.

Event Description

Refer to the inital-report.

• Brand Name: OXYLOG 3000
• Type of Device: VENTILATORS, TRANSPORT
• 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: 6943449
• MDR Text Key: 89262170
• Report Number: 9611500-2017-00301
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K062267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2009
• 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