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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA PRIMUS ANESHESIA UNITS Back to Search Results
Catalog Number 8607500
Device Problems Failure to Sense (1559); Use of Device Problem (1670); No Apparent Adverse Event (3189); Misassembled During Installation (4049)
Patient Problem Respiratory Distress Syndrome of Newborns (2046)
Event Date 05/04/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still on-going. The results will be provided with a follow-up report.
 
Event Description
It was reported that during a caesarian section sevo was reading very low so that the flow and sevo concentration was increased. When the problem was fixed the correct readings showed that the patient was adequately anaesthetized and that the gas sensor has given inaccurate readings. This resulted in the baby receiving more anesthetic than it was necessary and it required inflation breaths at delivery.
 
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Brand NamePRIMUS
Type of DeviceANESHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key11854046
MDR Text Key251660224
Report Number9611500-2021-00217
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 company representative,user f
Type of Report Initial,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8607500
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2012
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: 05/20/2021 Patient Sequence Number: 1
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