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

Catalog Number MK06000

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem Cyanosis (1798)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the involved perseus anesthesia device had been newly installed (the week prior the reported date of event on monday).The anesthesiologist had been trained on the device in that previous week, but the nurses had not.Against the recommendation of draeger, the clinical coordinators decided to leave the new machine in over the weekend to be used first thing monday morning.They were aware verbally and also according to the signed training plan, that the clinical application specialist would not arrive until 11:00am on monday to be present for training and to put the device into service.The draeger clinical application specialist arrived on the reported monday at approx.11:30am and waited outside the or.Then, he noticed the alarm on the monitor of the perseus in question, the patient was desaturating with a spo2 of 70%.He saw that while the patient was connected to the aux o2 outlet of the perseus, the device was set to ventilate through the emergency outlet (the toggle was pointed toward the emergency outlet instead of the aux o2).He entered the room immediately and turned the toggle down towards the aux o2.After changing the toggle position, the patient¿s spo2 recovered quickly.As it was reported additionally, the patient was slightly cyanotic during desaturation.

Manufacturer Narrative

Based on the investigation of the available information, no indications for a device malfunction were found.The evaluation of the detailed event description revealed that the device has been used without adequate knowledge prior to training of the users.Against the recommendation of dräger, the newly installed device was left over the weekend to be used on the reported date of event.In case the o2 switch is set to add.O2 but patient is connected to the aux.O2 outlet, as it was in this specific case, no oxygen flow is provided to the patient and can lead to a critical desaturation.In general, the perseus a500 alerts with a high priority alarm ¿fio2 low¿ to warn the user that the inspiratory o2 has fallen below the lower alarm limit.It was reported additionally, that the user did not know how the switch had toggled toward the emergency outlet (add.O2) position.However, if the add.O2 is active, during operation and standby mode, a corresponding ¿add.O2 activated¿ alarm is generated by the device.The usage of the emergency o2 delivery (add.O2) and the according alarms are described in the instructions for use of the perseus a500.Dräger finally concludes that the device worked as specified.The o2 switch being toggled to the wrong position o2 switch being set to add.O2 while the patient was connected to the aux.O2 outlet without noticing by the user has caused the reported event.

Event Description

Please refer to the initial report.

• 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: 7964308
• MDR Text Key: 123669545
• Report Number: 9611500-2018-00330
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)180509(17)181219(93)MK06000-34
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• 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: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening