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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 Degraded (1153); Failure to Deliver (2338); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2020
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 there was a ventilator failure during use. There was no injury reported.
 
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Brand NameAPOLLO
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
MDR Report Key10940576
MDR Text Key219351871
Report Number9611500-2020-00445
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier04048675229674
UDI-Public(01)04048675229674(11)200625(17)250306(93)8606500-67
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8606500
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 Received01/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2020
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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