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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS Back to Search Results
Catalog Number 8603800
Device Problems Use of Device Problem (1670); Failure to Deliver (2338)
Patient Problem Insufficient Information (4580)
Event Date 05/26/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the device alarmed for power fail as well as for ventilator failure during use.There was no detail in the report which would reasonably suggest that patient consequences have occurred.
 
Manufacturer Narrative
When the dispatched dräger service engineer checked the device on-site, the entries in the log file for the period in question were unfortunately overwritten due to the fact that the hospital's biomed had done a lot of testing with the workstation in follow-up of the event and, this has created new log entries.Based on the reported power fail alarm the power supply unit was replaced in abundance of caution despite no power fail could be duplicated during on-site evaluation of the device.The replaced power supply was subject to an in-depth testing in the manufacturer's lab but did not exhibit any non-conformities during these tests.Reflecting the absence of persisting technical error condition, a reasonable explanation would be that the device ran on internal batteries during the time of event until these were depleted.Due to missing detailed description of event and erased log file records this can't be verified.The device is back in use without further problems reported to date.
 
Event Description
It was reported that the device alarmed for power fail as well as for ventilator failure during use.There was no detail in the report which would reasonably suggest that patient consequences have occurred.
 
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Brand Name
PRIMUS
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
MDR Report Key12031978
MDR Text Key261549571
Report Number9611500-2021-00266
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8603800
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/26/2021
Initial Date FDA Received06/21/2021
Supplement Dates Manufacturer Received07/19/2021
Supplement Dates FDA Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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