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

Catalog Number MK06000

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

The concerned device is a dräger anaesthesia workstation perseus a500 with serial number (b)(4) which was manufactured in 06/2014.The electronic log file of the device was available for investigation.We have analyzed the information stored therein and would like to provide you with our results hereinafter.On the reported date of event, the system test was successfully completed at 6:46.The case in question was started at 11:57 using man/spont mode to manually ventilate the patient during induction.From 12:03 on volume af mode was active and the patient was ventilated automatically.Just from the beginning the perseus repeatedly detected deviations between the measured inspiratory and expiratory volume.This clearly indicates a significant circuit leak outside the device, e.G.Located in the breathing circuit set, the y-piece or the et tube.The perseus reacted as designed and generated corresponding visible and audible alarms such as apnea, minute volume low and tidal volume not achieved.As a result of the leak a fresh gas deficit occurred and was also detected by the perseus, which repeatedly posted a fresh gas low or leakage alarm.Subsequently the user switched between man/spont and volume af mode multiple times, without any improvement of situation.Between approximately 12:25 and 12:48 a stable ventilation could be established.After that the similar deviations in measured inspiratory and expiratory volume were recurring with identical consequences as before.A fresh gas deficit occurred and at 12:49 the perseus activated the emergency air inlet to compensate it.The situation remained unstable and several apnea, inspiratory tidal volume high, fresh gas low or leakage and minute volume low alarms were given until 13:03 when the procedure was obviously finished by switching the device to standby mode.The analysis of the device log file records has not revealed any malfunction of the perseus anaesthesia workstation.The recorded information clearly indicates that significant leakages in the patient circuit (outside the device) were present.These leakages restricted delivery of gas to the patient and impacted both airway pressure and the applied volume.The perseus was operating properly at any time; the integrated gas monitoring and the alarm system were working according to specifications as well.

Event Description

The customer reported that a patient suffered from a deterioration in state of health when the perseus ventilator failed.

Event Description

Please refer to the initial report.

Manufacturer Narrative

In addition to what was initially reported the anaesthetist in charge during that event has alleged that the dräger machine used during the incident was faulty in a way that it did not generate alarms.The electronic log file covering the reported date of event was available for investigation.On (b)(6) 2017, the reported date of event, the system test, which is an automated test routine checking if the device is ready for use, was successfully completed at 06:46.The case in question was started at 11:57 using man/spont mode to manually ventilate the patient du ring induction.From 12:03 on, volume af mode was active and the patient was ventilated automatically.The perseus repeatedly detected deviations between the measured inspiratory and expiratory volume.This clearly indicates a significant circuit leak outside the device, e.G.Located in the breathing circuit set, the y-piece or the et tube.Due to this leak the set volumes could not be applied and a lack of fresh gas occurred.The perseus reacted as specified for this situation and generated corresponding visible and audible alarms such as apnea, minute volume low, tidal volume not achieved and fresh gas low or leakage to indicate the restriction of ventilation to the user.Subsequently the user repeatedly switched between man/spont and volume af mode without any improvement of the situation.Between approximately 12:25 and 12:48 a stable ventilation could be established.After that similar deviations in measured inspiratory and expiratory volume were recurring with identical consequences as before.At 12:49 the perseus activated the emergency air inlet to compensate the fresh gas deficit.The situation remained unstable and several further alarms were given until 13:03 when the procedure was obviously finished by switching the device to standby mode.The analysis of the device log file records has not revealed any malfunction of the perseus anaesthesia workstation.The recorded information clearly indicates that significant leakages in the patient circuit (outside the device) were present.These leakages restricted delivery of gas to the patient and impacted both airway pressure and the applied volume.The perseus was operating properly at any time and posted numerous audible and visible alarms to indicate the restriction to the user.The reported lack of alarming of the device could not be confirmed.The system test that the device successfully passed in the morning also includes a specific test to verify proper functionality of the audible alarm system.A corresponding "sound check passed" entry was logged during the system test at 06:38 which provides evidence that the alarm speaker was functional at that time.In addition, the perseus generates 2 acoustic signals at the end of the system test.The perseus instructions for use, chapter system test, advise the user to contact service in case these signals are not generated (see attached excerpt).Given the fact that the user decided to put the device into operation we conclude that these signals were generated properly.Since in theory it may happen that the alarm speaker fails after these tests, the perseus also features a continuous speaker monitoring which verifies proper generation of each acoustic alarm during use.There is a secondary alarm buzzer as a backup for such case.Once an acoustic alarm is triggered and the integrated speaker does not respond as specified a corresponding speaker failure message would be displayed and the secondary alarm buzzer would be activated.This buzzer generates an alarm tone that is significantly louder than the usual acoustic alarms and would thus definitely be obvious to the user.The aforementioned speaker failure would also be stored in the log file.No such entry could be found.Given the recorded test result, the fact that the user decided to put the device into operation and the lack of speaker failure entries we conclude that the audible alarm system was fully functional.

• 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: 8273602
• MDR Text Key: 133959766
• Report Number: 9611500-2019-00025
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• 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: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening