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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1011-9000-000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Death (1802)
Event Date 03/29/2019
Event Type  Death  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient id and patient weight unavailable.Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported a patient death during a complex wound procedure being performed on a (b)(6) year old obese female paraplegic patient with multiple comorbidities in the prone position.There is no allegation of anesthesia machine malfunction at this time.
 
Manufacturer Narrative
Ge healthcare product engineering performed an investigation of this event.A ge healthcare service representative retrieved the logs for the time this event occurred (b)(6) 2019 at 12:00:00), as requested by the customer for an internal investigation.The logs show the final day of use before the logs were obtained was b)(6) 2019.Review of the device logs for the second and final case on 29-mar-2019 did not reveal any resets or stoppages of the device.At 1:15 pm the device reported a positive end expiratory pressure (peep) pressure control ventilation (pcv) not available alarm which cleared after three minutes.The device was in volume control ventilation (vcv) at the time of the alarm, so ventilation was not lost.The alarm activation and deactivation is highlighted in the logs.The user continued to ventilate with the device for an hour until the end of the case.Parameter alarms were present throughout the case but there is no indication of a device malfunction causing or contributing to their presence.The customer has made no allegation of failure against the system.A root cause cannot be established as there was no allegation of fault against the device.Because there is no allegation of failure and there is no evidence of system malfunction, it is determined that the device did not cause or contribute to the patient demise.
 
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Brand Name
AISYS
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key8560166
MDR Text Key143393733
Report Number2112667-2019-00182
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model Number1011-9000-000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/05/2019
Initial Date FDA Received04/29/2019
Supplement Dates Manufacturer Received05/24/2019
Supplement Dates FDA Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age25 YR
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