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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 Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
The device is not under service contract; the hospital performs maintenance and repair activities on own behalf and responsibility. There was no log file made available which would cover the period in question. The hospital's biomed reported the presence of certain error codes in the logs and that the unit passed a power-on self test which was performed in follow-up of the event without any deviations. The particular error codes indicate that the device did not sense valid breaths during the course of the concerned procedure and thus, alarmed for apnea. It could not be clarified if these were the only error codes that were recorded for the period in question or not. Without the presence of secondary alarms which would point to technical error conditions, the records rather indicate that the device indeed did not stop to ventilate but that ventilation was disturbed by a large external leakage in the patient circuit. This assessment is substantiated by the fact that device passed the test in follow up of the event and did not exhibit any malfunction. However, without having the possibility to analyze the log file, the presence of a technical error condition and the validity of the reportedly observed stop of ventilation cannot be fully ruled out. Hence, this report is being filed in abundance of caution.
 
Event Description
It was reported that the ventilator stopped ventilating during a case. The patient was bagged and the case was finished. There was no patient 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 Key11377126
MDR Text Key245315354
Report Number9611500-2021-00087
Device Sequence Number1
Product Code BSZ
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
Report Date 02/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8606500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2017
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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