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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS Back to Search Results
Catalog Number 84156000
Device Problems Decrease in Pressure (1490); Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Patient Problem Low Oxygen Saturation (2477)
Event Date 11/02/2023
Event Type  Injury  
Event Description
It was reported that the o2 supply cutoff during the case and the patient o2 saturation dropped below 70%.The anesthetist used the o2 flush button.Oxygen was available and patient condition became better.So, they cancelled the case and tested the unit.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
 
Manufacturer Narrative
The electronic log file was available form investigation.The reported symptom could be reconstructed by means of the information stored therein.The log entries do not indicate any device failure.Based on what was recorded in the log ventilation was restricted due to a leakage/disconnection in the patient circuit and the resulting fresh gas deficit and thus a reduced fio2.Appropriate alarms (e.G., apnea, minute volume low, fresh gas low or leakage) were given during the case to call the attention of the user.All alarms, possible causes and remedies are described in the instructions for use.The investigation has not revealed a device failure.
 
Event Description
It was reported that the o2 supply cutoff during the case and the patient o2 saturation dropped below 70%.The anesthetist used the o2 flush button.Oxygen was available and patient condition became better.So, they cancelled the case and tested the unit.
 
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Brand Name
PERSEUS A500
Type of Device
ANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key18128834
MDR Text Key327991048
Report Number9611500-2023-00406
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number84156000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.
Patient Outcome(s) Hospitalization;
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