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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 Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)
Patient Problem Insufficient Information (4580)
Event Date 05/05/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
Event Description
It was reported that there was a ventilator failure message displayed during a case.The patient was bagged to finish the case.No patient injury reported.
 
Event Description
It was reported that there was a ventilator failure message displayed during a case.The patient was bagged to finish the case.No patient injury reported.
 
Manufacturer Narrative
Upon checking the log files the hospital's biomed could confirm the observed shut-down of automatic ventilation.The engineer identified problems with the ventilator motor and ordered a motor assembly for replacement, consequently.Evaluation of the returned original motor performed in the manufacturer's lab revealed that wear-and-tear related abrasion of the collector disc had resulted in development of positions where the motor does not provide mechanic power due to contact interrupts to the carbon brushes; speed fluctuations will be the consequence.Since the motor speed is being monitored continuously, the speed fluctuations result in a deviation between measured and expected piston position.To prevent from potentialy hazardous output and/or from damages to the ventilator unit the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component after almost 15 years of use; no patient consequences have been reported.The repair exchange will fully solve the device problem.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
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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 Key11900004
MDR Text Key256167036
Report Number9611500-2021-00229
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 07/13/2021
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 05/14/2021
Initial Date FDA Received05/28/2021
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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