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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V600; VENTILATORS, INTENSIVE CARE

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DRÄGERWERK AG & CO. KGAA EVITA V600; VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8422300
Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019); Intermittent Communication Failure (4038)
Patient Problem Insufficient Information (4580)
Event Date 12/27/2020
Event Type  malfunction  
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 performed a shutdown during the ventilation.No patient consequences have been reported.
 
Manufacturer Narrative
The analysis of the available description of event revealed that the service technician found a faulty pba m48.3 circuit board onsite as the root cause in the reported event.The replacement of the affected part solved the problem.In case of a complete loss of function of the ventilator, the safety valve automatically opens to ambient allowing the patient for spontaneous breathing.The secondary acoustic alarm system (piezo speaker) of the ventilation unit will be activated in order to alert the user to the situation.This alarm is energized from an independent power source and will be last for at least 2 minutes.There was no patient injury reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that the device has performed a shutdown during the ventilation.No patient consequences have been reported.
 
Event Description
It was reported that the device has performed a shutdown during the ventilation.No patient consequences have been reported.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Not returned to manufacturer.
 
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Brand Name
EVITA V600
Type of Device
VENTILATORS, INTENSIVE CARE
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 Key11751542
MDR Text Key250431386
Report Number9611500-2021-00188
Device Sequence Number1
Product Code CBL
Combination Product (y/n)N
PMA/PMN Number
EUA 200143
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8422300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/13/2021
Initial Date FDA Received04/30/2021
Supplement Dates Manufacturer Received06/25/2021
06/25/2021
Supplement Dates FDA Received07/01/2021
06/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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