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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 MK06000
Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Calibration Problem (2890)
Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)
Event Date 06/04/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation was started. The results will be sent within a follow-up report.
 
Event Description
It was reported that while an already critical patient was ventilated a loss of tidal volume occurred. At this patient the vt decreased from about 450 ml to below 180 ml. As a consequence, the user calibrated the flow measurement three or four times and the vt values improved temporarily. In the following the vt decreased again, a renewed calibration did not improve the vt values. The user disconnected the critical patient and continued the ventilation with another ventilator. No immediate injury resulting of the incident was reported. However, it could not be excluded by the user that the incident contributed to the deterioration in health. The patient died three days after the incident.
 
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Brand NamePERSEUS A500
Type of DeviceANESTHESIA UNITS
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
Manufacturer Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key9097087
MDR Text Key165040397
Report Number9611500-2019-00280
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K133886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Device Catalogue NumberMK06000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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