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

Catalog Number MK06000

Device Problems No Device Output (1435); Use of Device Problem (1670); Failure to Deliver (2338); Device Handling Problem (3265)

Patient Problems Death (1802); No Information (3190)

Event Date 11/07/2019

Event Type  Death  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that the oxygen supply was unplugged by mistake and that the corresponding posted alarms were silenced and reset.The patient reportedly died.

Event Description

Please refer to initial mfr.Report #9611500-2019-00390.

Manufacturer Narrative

The device log indicates that the last system test was performed in the afternoon of the day before the reported date of event and was passed w/o deviations.It can furthermore be revealed that, 16 minutes before the procedure in question was started, the device which was in standby mode alarmed for central o2 supply low indicating a disconnection from wall supply.The user then started a procedure in manual ventilation.The workstation almost immediately warned the user that no oxygen is being delivered.The device also alarmed for fio2 low since the measured concentration was between 19 and 25 vol%.In the following there were multiple instances logged where the user acknowledged the posted alarms with the 2-minute-silence button.Approx.Half an hour into the procedure the no o2 delivery alarm was removed, indicating the o2 central supply was available again.The measured fio2 remained low around 20vol% confirming that the sample line was disconnected as reported.Ten minutes later the fio2 suddenly increased to 94vol% - the sample line obviously was reconnected to the circuit at this point in time.There were no indications for the potential presence of a device malfunction found.Dräger finally concludes that the event was related to an improper connection of the workstation to the central gas supply.The device posted the corresponding alarms but the user obviously did not respond to them in an appropriate time.All alarms, potential causes & triggering conditions as well as dedicated remedies are described in the instructions for use.

• 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: 9353012
• MDR Text Key: 167312689
• Report Number: 9611500-2019-00390
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death