MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Calibration Problem (2890)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation was started.The results will be sent within a follow-up report.

Event Description

It was reported that while an already critical patient was ventilated a loss of tidal volume occurred.At this patient the vt decreased from about 450 ml to below 180 ml.As a consequence, the user calibrated the flow measurement three or four times and the vt values improved temporarily.In the following the vt decreased again, a renewed calibration did not improve the vt values.The user disconnected the critical patient and continued the ventilation with another ventilator.No immediate injury resulting of the incident was reported.However, it could not be excluded by the user that the incident contributed to the deterioration in health.The patient died three days after the incident.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

The course of event was reconstructed by means of log file analysis.There's evidence in the records that the device passed the power-on self-test in the morning of the date of event without deviations.The case in question was started at 10:32 am using volume control af mode.The ventilation was stable and unremarkable until about 15:00.From this point in time, considerable deviations between inspiratory and expiratory volumes were detected leading to a restricted ventilation as well as a fresh gas deficit.Several apnea and fresh gas low or leakage alarms were given.In the further course the emergency air inlet was opened autonomously.At 15:17 the unit was placed in standby.The evaluation of the electronic device log file revealed no indications for a technical malfunction, neither during nor before or after the reported event.The log gives no indication for a malfunction.It can however not be excluded that a temporary malfunction of the rotary knob has occurred but the data in the log demonstrates that mode and setting changes were possible to execute throughout the whole procedure.The last 15 to 20 minutes were disturbed by a large leakage which led to fresh gas deficit and restrictions in ventilation.Appropriate alarms were posted.The rotary knob was replaced as a precautionary measure.The device was tested and returned to use w/o any further problems reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9097087
• MDR Text Key: 165040397
• Report Number: 9611500-2019-00280
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1