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

Catalog Number 8607380

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

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 the device had a ventilator failure during use.There was no patient injury reported.

Manufacturer Narrative

The device was tested in follow-up of the event and did not exhibit any malfunction; a self-test was passed without deviations and a ventilation episode with a test lung could be performed w/o problems.The evaluation of the electronic log file revealed that the concerned procedure was suffering from the beginning from a disturbed ventilation.The device alarmed repeatedly for apnea, airway pressure high and insp co2 high.After about 40 minutes the device started to alarm for a fresh gas deficit, in the following the ventilator was not able anymore to apply the set tidal volumes.Another 7 minutes later the device measured negative and positive pressure peaks (<-20mbar, +70mbar) while the ventilator piston was blocked at the upper end position.The workstation responded with a shutdown of automatic ventilation.Dräger finally concludes that there is no issue with the device which would require repair or correction.The disturbances of the ventilation were brought to the user's attention by corresponding alarms.The fresh gas deficit worsened over several minutes and led to a blocking of the ventilator piston at the end wherupon the device responded with shutdown of automatic ventilation.The origin of the massive pressure fluctuations that led to the blocking cannot be derived from the available information; imaginable would be spontaneous breathing of the patient or the use of a bronchial suction system.

Event Description

Please refer to initial mfr.Report #9611500-2020-00254.

• Brand Name: PRIMUS INFINITY EMPOWERED
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10313190
• MDR Text Key: 200039729
• Report Number: 9611500-2020-00254
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607380
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1