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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC VENTILATORS, INTENSIVE CARE

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DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8416000
Device Problem Device Alarm System (1012)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Oxygen Saturation (2477)
Event Date 05/06/2019
Event Type  Injury  
Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

 
Event Description

It was reported that the device has failed on (b)(6) 2019 at approx. 5:25 am without alarming a device error or displaying an error message. As a result of the patient not being ventilated, o2 saturation dropped to 44% and blood pressure increased. The patient was given antihypertensives. Furthermore, the patient received 100% oxygen.

 
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Brand NameINFINITY ACS WORKSTATION CC
Type of DeviceVENTILATORS, INTENSIVE CARE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key8619053
MDR Text Key145344125
Report Number9611500-2019-00153
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK093633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2000
Device Catalogue Number8416000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/31/2016
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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