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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS ANESTHESIA UNIT

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DRÄGERWERK AG & CO. KGAA PRIMUS ANESTHESIA UNIT Back to Search Results
Catalog Number 8603800
Device Problems Failure to Read Input Signal (1581); Failure to Deliver (2338); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
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 a ventilator failure occurred during a surgical procedure. The patient was connected to another device; no health consequences have reportedly occurred.
 
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Brand NamePRIMUS
Type of DeviceANESTHESIA UNIT
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 Key12966805
MDR Text Key283503810
Report Number9611500-2021-00496
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 User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8603800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2015
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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