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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE VENTILATORS, INTENSIVE CARE

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DRÄGERWERK AG & CO. KGAA INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8416400
Device Problems Delayed Alarm (1011); Premature Discharge of Battery (1057); Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2016
Event Type  malfunction  
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 customer reported that the ps500 battery showed a full charge on the cockpit screen before disconnecting ac power from the ventilator. After disconnecting ac power to the ventilator and while transporting a patient, the message "battery low" was posted after 10 minutes. Approximately 15 minutes after disconnecting ac power from the ventilator (5 minutes after "battery low" alarm), the ventilator shut down completely and a loud continuous audible alarm was heard. The customer then plugged ventilator ac power cord back into ac power and the ventilator powered back on and was again operational. No patient injury was reported.
 
Manufacturer Narrative
The provided log files were analyzed. The user's observation of an unexpected battery capacity loss could be confirmed. Investigation revealed that a non-specified unexpected reduction of battery capacity occurred when using the ps500 with fw1. 49 and battery characteristics 01052 which resulted in a shortened battery operating time. If the battery is discharged and the mains supply is missing the device posts an independently energized acoustical power loss alarm which lasts at minimum for 2 minutes. The device will stop ventilating and the airway system is opened to allow spontaneous breathing. After replacement of the batteries the device was checked and found to be fine, which includes the alarm functions. A fsca has been initiated and already reported. The herein included safety note was published which the user was aware of. Although the customer was aware about that safety note, the device was not made available for battery replacement.
 
Event Description
Please see initial-report.
 
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Brand NameINFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
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 Key6154163
MDR Text Key62325358
Report Number9611500-2016-00374
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Device Catalogue Number8416400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/30/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0827-2016

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