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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 Gas Output Problem (1266); Leak/Splash (1354); Mechanical Problem (1384); Failure to Sense (1559); Failure to Deliver (2338); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
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 the device posted reinstall vent alarms intermittently. 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 Key9621053
MDR Text Key176097399
Report Number9611500-2020-00023
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK042607
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 02/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/23/2020
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Ageyr
Event Location No Information
Date Manufacturer Received12/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/31/2006
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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