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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS INFINITY EMPOWERED ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA PRIMUS INFINITY EMPOWERED ANESTHESIA UNITS Back to Search Results
Catalog Number 8607600
Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation was just started. The result will be forwarded in a follow-up report.
 
Event Description
It was reported that only manual ventilation was possible during operation. No injury reported.
 
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Brand NamePRIMUS INFINITY EMPOWERED
Type of DeviceANESTHESIA UNITS
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key13678239
MDR Text Key289767229
Report Number9611500-2022-00063
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
Type of Report Initial,Followup
Report Date 05/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8607600
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/07/2022 Patient Sequence Number: 1
Treatment
NA.
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