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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY ADU ANESTHESIA GAS MACHINE

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GE HEALTHCARE FINLAND OY ADU ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 10/03/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The central processing unit (cpu) was replaced to resolve the reported issue. No report of patient involvement. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
 
Event Description
The hospital reported that the unit displayed a communication error. There was no report of patient involvement.
 
Manufacturer Narrative
Engineering evaluation has determined that this malfunction will not cause a loss of mechanical ventilation. The main software sends messages automatically five times in case of any error in communication, and thus this error situation is solved automatically. Per the complaint, the device was able to perform manual and mechanical ventilation. This was not a reportable malfunction. Engineering evaluation has determined that this malfunction will not cause a loss of mechanical ventilation. The main software sends messages automatically five times in case of any error in communication, and thus this error situation is solved automatically. Per the complaint, the device was able to perform manual and mechanical ventilation. This was not a reportable malfunction.
 
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Brand NameADU
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki FIN-0 0510
FI FIN-00510
MDR Report Key8018797
MDR Text Key125461482
Report Number9610105-2018-00051
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K050676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

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