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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 8603800
Device Problems Gas Output Problem (1266); Use of Device Problem (1670); No Apparent Adverse Event (3189)
Patient Problem Cyanosis (1798)
Event Date 01/21/2022
Event Type  Injury  
Manufacturer Narrative
The investigation was just started, the result will be forwarded in a follow-up report.
 
Event Description
It was reported that the patient 'turned blue' and it was found the device was not delivering 100% oxygen as selected. A 'no fresh gas alarm' was given. Only 17% oxygen.
 
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Brand NamePRIMUS INFINITY EMPOWERED
Type of DeviceANESTHESIA 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 Key13478787
MDR Text Key285217090
Report Number9611500-2022-00038
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8603800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2009
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: 02/08/2022 Patient Sequence Number: 1
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