MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH PRIMUS IE; ANESTHESIA UNITS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)

Event Date 03/11/2015

Event Type  Injury  

Event Description

It was reported: during the first ventilation everything was okay, but after a certain time the saturation dropped and the child became blue.According to dr.(b)(6) problems only occur in children anesthesia and completely randomly.Meanwhile, the anesthetics are already done by 2 persons, in order to avoid human error.There was no permanent damage or clinical intervention reported.

Manufacturer Narrative

Device check and log analysis showed not device errors.A further analysis of user logs now ((b)(4) 2015) has shown that repeatedly changed settings have not been confirmed via the rotary knob.Therefore, these were not accepted by the device.The affected device was requested in lubeck for closer examination.Due to the analyzed log of the user's behavior, the user was offered a retaining on site by the drager sales on (b)(4) 2015.

• Brand Name: PRIMUS IE
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; moislinger allee 53-55; luebeck 2354 2; GM 23542
• Manufacturer Contact: frank clanzett ; moislinger allee 53-55; luebeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 4707506
• MDR Text Key: 5720904
• Report Number: 9611500-2015-00029
• 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: User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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): Life Threatening