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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA PALLAS ANESTHESIA UNITS Back to Search Results
Catalog Number 8608500
Device Problem Loss of Power (1475)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2018
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 during ventilation the device stopped accompanied by a "ventilator failure" alarm. Only man/spont possible. No patient injury reported.
 
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Brand NamePALLAS
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 Key8256215
MDR Text Key133485009
Report Number9611500-2019-00011
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Device Catalogue Number8608500
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 Received01/18/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/31/2010
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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