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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC VENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC

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DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC VENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC Back to Search Results
Catalog Number 8415000
Device Problem Ventilation Problem in Device Environment (3027)
Patient Problems Death (1802); Pneumonia (2011); Pneumothorax (2012)
Event Date 11/29/2016
Event Type  Death  
Manufacturer Narrative

The investigation was started but is not yet concluded. The investigation result will be reported in a follow up-report.

 
Event Description

The hospital reported that the patient ventilated by a vn500 developed pneumonia. The user believes that this occurred due to excess condensation that is generated during the ventilation. During ventilation the heated humidifier fp mr850 was used. The user treated the patient with the following medications: ampicillin + garamycin, furosemide, dobutamine, oxacillin + amikacin, fluconazole, vancomycin + meropenem, decadron, pulmicort inhaled, bactrim. The patient died on (b)(6) 2016.

 
Manufacturer Narrative

The affected device has been checked by a dräger technician and passed all tests according to specification without deviation. Analysis of the log file shows that several audible and visual alarms such as ¿vt low¿, ¿airway obstructed¿, ¿paw high¿, ¿fluid in expiratory valve¿ and ¿neonatal flow sensor soiled¿ were generated over multiple days around the date of event. No malfunction of the device could be detected. Those alarms indicate an impaired ventilation due to condensate in the breathing circuit as was reported by the user. The amount of condensate generated during ventilation depends on environmental conditions, ventilation settings and the application set-up. Those information were requested for the investigation, but were only partly provided. The ifu describes that water traps shall be used and placed within the breathing circuit to avoid water oscillation. The water traps have to be monitored and evacuated to ensure proper ventilation. It can be concluded that the device behaved as specified during the event.

 
Event Description

Please see initial-report.

 
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Brand NameINFINITY ACS WORKSTATION NC
Type of DeviceVENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC
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 Key6266010
MDR Text Key65352108
Report Number9611500-2017-00018
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK093632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2017
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 Number8415000
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 Received03/08/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/30/2015
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: 01/20/2017 Patient Sequence Number: 1
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