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

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that, during operation, two primus anesthesia devices (sn: (b)(4)) failed with ¿ventilator failure¿ and ¿only manual ventilation available¿.During anesthesia, the patient was breathing spontaneously.After the second primus device failed with vent failure, the patient was being manually ventilated until end of operation.There was no patient injury reported.

Manufacturer Narrative

The ventilator failure of the second primus device (sn: (b)(4)) described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.The autonomous safety shutdown of the ventilator was triggered by a significantly increased airway pressure peak.The reason for this was an existing lack of fresh gas in combination with spontaneous breathing efforts of the patient, as it was already reported about the first primus (sn: (b)(4)).The device in question behaved as specified with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.In order to avoid situations like this in the future, it was recommended to switch on the synchronization for spontaneously breathing patients (e.G.Pressure mode with activated trigger) or use synchronized ventilation mode (e.G.Pressure support).The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

Please refer to the initial-report.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8173159
• MDR Text Key: 130979861
• Report Number: 9611500-2018-00402
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1