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

Catalog Number MK06000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 04/04/2018

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 a patient suffered from cardiac arrest when being transferred from one anesthesia machine used for induction to the second one which was intended to be used for surgery.The users alleged no device malfunction.The case happened in (b)(6) 2018 already but draeger was not made aware before (b)(6) 2018.Patient outcome could not be clarified at the date of reporting.

Event Description

Please refer to initial mfr.Report.

Manufacturer Narrative

The user facility provided screen shots of the log section that covers user interactions and patient related alarms.The other log section which would - if any was present, contain the records of technical error conditions was not available.The transmitted photos did not cover the data strings of the recorded events in its full length and thus, a reconstruction of patient parameter measurement data is not possible.There was however no indication for the presence of a device malfunction.This conclusion is also based on the hospital's own recapitulation of the course of events which was transmitted to dräger in written form - there was no allegation of malfunction of one of the involved dräger anesthesia machines.As described in the user's summary both devices had posted several alarms while the patient was connected - these alarms point to difficulties in achieving the intended ventilation.The devices had alarmed deviations between the set ventilation parameter and the measured ones - "minute volume low" was posted as well as alarms that indicate continuous high airway pressure.Low values of the patient's co2 readings were also brought to the user's attention by corresponding alarms.As already mentioned - none of the described alarm types is triggered upon detection of a technical problem; all are related to restricted ventilation.A reliable conclusion in regard to the exact root cause is impossible due to the missing of relevant data.It can rather be excluded that the devices had been a contributing factor in the deterioration of the patient's health status.

• 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: 8168492
• MDR Text Key: 130462085
• Report Number: 9611500-2018-00400
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)151112(17)160409(93)MK06000-30
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• 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?: No
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening