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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA 300; VENTILATORS, INTENSIVE CARE
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DRÄGERWERK AG & CO. KGAA SAVINA 300; VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8417801
Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
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 switched off itself during transport from the cardiac catheter laboratory (translation of: (b)(6)) to the icu.The device had been connected to oxygen and power source of the supply unit before.The procedure at the cardiac catheter laboratory lasted for 60 minutes.There were no patient health consequences reported.
 
Event Description
It was reported that the device switched off itself during transport from the cardiac catheter laboratory (translation of: hkl / herzkathederlabor) to the icu.The device had been connected to oxygen and power source of the supply unit before.The procedure at the cardiac catheter laboratory lasted for 60 minutes.There were no patient health consequences reported.
 
Manufacturer Narrative
The investigation was carried out based on the description of the event, considering the entries still available in the logbook.The day of the event was no longer shown in the logbook; the device was still in use after the event and older entries were overwritten.Based on the investigation, a problem with the internal battery could be verified; a faulty or heavily aged internal battery may have led to the described device failure during transport.Due to the missing entries of the logbook for the day of the event, it could not be conclusively clarified whether the device alerted the remaining capacity of the internal battery as specified before the failure occurred.However, the logbook suggests that - contrary to what was reported - there was an alarm of the failure of the internal battery by means of a power failure alarm.The audible power failure alarm of at least 2 minutes is generated via the redundant buzzer using a charged capacitor.Since the device was still in use after the day of the event and the device check was also successfully run afterwards, the acoustic alarm must have worked.The function of the buzzer is checked as part of the device check.In the current event the internal battery has to be replaced.The device should also be equipped with an external battery that provides additional operating time for intra-hospital transport and prevents premature wear of the internal battery.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field.
 
Event Description
It was reported that the device switched off itself during transport from the cardiac catheter laboratory (translation of: hkl / herzkathederlabor) to the icu.The device had been connected to oxygen and power source of the supply unit before.The procedure at the cardiac catheter laboratory lasted for 60 minutes.There were no patient health consequences reported.
 
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Brand Name
SAVINA 300
Type of Device
VENTILATORS, INTENSIVE CARE
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 Key11783286
MDR Text Key251734755
Report Number9611500-2021-00198
Device Sequence Number1
Product Code CBK
UDI-Device Identifier04048675251422
UDI-Public(01)04048675251422(11)190226(17)220101(93)8417800-38
Combination Product (y/n)N
PMA/PMN Number
K180779
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,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8417801
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.; NA.
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