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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA PERSEUS A500 ANESTHESIA UNITS Back to Search Results
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.

 
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Brand NamePERSEUS A500
Type of DeviceANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key8273602
MDR Text Key133959766
Report Number9611500-2019-00025
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation BIOMEDICAL ENGINEER
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 Received01/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2000
Device Catalogue NumberMK06000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/30/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 01/24/2019 Patient Sequence Number: 1
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