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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS Back to Search Results
Catalog Number 8606500
Device Problem No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2019
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 there was a ventilator fail during use.There was no injury reported.
 
Manufacturer Narrative
The investigation was performed based on the given information including the electronic log file.The case in question could be reconstructed by means of the information stored therein.On 15:24 on the reported date of event the device detected an encoder check error.This indicates a problem with the position detection of the ventilator piston.A failure of the motor or the light barrier cable of the ventilator assembly is considered the most likely root cause.The apollo reacted as specified as it shut down automatic ventilation and posted a corresponding visible and audible ventilator fail alarm.In such case manual ventilation and monitoring remain available to continue the case.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
Please refer to the initial-report.
 
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Brand Name
APOLLO
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key9389428
MDR Text Key186752117
Report Number9611500-2019-00401
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 11/28/2019
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 Number8606500
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/01/2019
Initial Date FDA Received11/28/2019
Supplement Dates Manufacturer Received12/18/2019
Supplement Dates FDA Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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