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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Distress (2045)

Event Date 06/11/2015

Event Type  Injury  

Event Description

It was reported that "during the surgical operation, the respirator stopped to push the volume wished.The autotest had been made and had passed with no problem." the patient reportedly developed a hypercapnia in recovery room.The patient was re-intubated and reportedly transported in resuscitation.

Manufacturer Narrative

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

Manufacturer Narrative

The device was tested by the service technician.All tests were passed according to specification and the device was returned to use.The technician downloaded the logfile.The description of the event and the logfile returned provided a basis for the investigation.All information available were analyzed regarding the reported restricted volume delivery the reported symptom could be confirmed as the logfile revealed that the device repeatedly alarmed for "apnea, "inspiratory pressure not attained", "minute volume low" indicating a significant circuit leak indications for a product malfunction were not present, as e.G., a peep valve failure or a leakage in the internal pneumatics of the device would have been documented within the logfile.The root cause is most likely an untight connection causing limited pressure and volume to the pt.Significant circuit leakage may restrict sufficient ventilation and oxygenation of the patient leakage is measured within the pre operation self test and during ongoing ventilation resulting into corresponding alarms.Further measures were not taken as the device was tested and returned to use.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; 53/55 moislinger allee; lubeck 23542 ; GM 23542
• Manufacturer Contact: frank clanzett ; 53/55 moislinger allee; lubeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 4909752
• MDR Text Key: 21931381
• Report Number: 9611500-2015-00115
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2015

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: 06/16/2015
• Initial Date FDA Received: 06/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2005
• 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