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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 Problems Gas Output Problem (1266); Decrease in Pressure (1490); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2022
Event Type  malfunction  
Event Description
It was reported that the device did a reboot. There was no patient injury reported.
 
Manufacturer Narrative
For the investigation the logfile was analyzed. On the reported date of event the case in question was started using man/spont. After changing to volume control af ventilation was unremarkable and stable. After about one hour of operation a communication interrupt between both processors of the therapy control unit m16. 2 was detected, in consequence leading to a processor reset. Therapy was discontinued for a maximum of 15 seconds before therapy resumed with the latest valid settings. The exact root cause for the communication interrupt between the processors of the therapy control unit m16. 2 couldn¿t be determined as the requested hardware was not made available for investigation. Dräger finally concludes that the workstation has responded to the malfunction of a single component as designed - a reboot was performed to overcome the error condition and the appropriate alarm was posted. The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
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Brand NamePERSEUS A500
Type of DeviceANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key15282297
MDR Text Key302969946
Report Number9611500-2022-00214
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675253600
UDI-Public(01)04048675253600(11)191120(17)200628(93)MK06000-38
Combination Product (y/n)N
PMA/PMN Number
K133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMK06000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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