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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS TIRO ANESTHESIA UNITS

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DRÄGERWERK AG & CO. KGAA FABIUS TIRO ANESTHESIA UNITS Back to Search Results
Catalog Number 8606000
Device Problems Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2021
Event Type  malfunction  
Manufacturer Narrative
The device is not under a service contract and, since no serial number information is available, the age of the device is unknown. Dräger contacted the user facility to obtain further information. The only additional detail that was provided is that the device is back in use after a repair ingress made by the hospital's biomed who re-soldered a contact point at the controller board to remove the error condition. The exact area where the faulty solder point was located was not named and thus, a case-specific evaluation is not possible. It is even not clear if the error condition was related to the manufacturing process or if a previously performed repair ingress has caused the problem. Dräger finally concludes that an unspecific error condition in the electronic control mechanisms of the device has led to shut-down of automatic ventilation. If such condition occurs the device will post a corresponding alarm to alert the user. Manual ventilation with the built-in breathing bag remains possible and, it is unlikely that the error condition has an effect on the set-up of patient monitoring.
 
Event Description
It was reported that the automatic ventilation suddenly stopped during use of the device. Patient support was continued in manual ventilation; no consequences have reportedly occurred.
 
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Brand NameFABIUS TIRO
Type of DeviceANESTHESIA 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
MDR Report Key12165108
MDR Text Key263474700
Report Number9611500-2021-00306
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8606000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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