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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS ANESTHESTIA UNITS

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DRÄGERWERK AG & CO. KGAA PRIMUS ANESTHESTIA UNITS Back to Search Results
Catalog Number 8603800
Device Problem Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2022
Event Type  malfunction  
Manufacturer Narrative
The evaluation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the device suddenly alarmed for ventilator failure and shut down automatic ventilation. The users performed manual ventilation towards the end of the procedure; no patient consequenes have reportedly occurred.
 
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Brand NamePRIMUS
Type of DeviceANESTHESTIA 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 Key15197393
MDR Text Key303753535
Report Number9611500-2022-00202
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675041436
UDI-Public(01)04048675041436(11)190730(93)8603800-95
Combination Product (y/n)N
PMA/PMN Number
K042607
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,Followup
Report Date 09/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8603800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age3 YR
Date Manufacturer Received09/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
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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