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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
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ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Back to Search Results
Catalog Number 03R70-01
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2024
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported smoke from the back of the monitor on the alinity ci-series system control module.The customer initially reported wz2 flush failed errors occurred and after a power cycle the monitor screen remained black when powering back up.When the computer was powered on with switch on the pc itself, it generated the following error 'aim=0274 | sub_aim= | improper shutdown on user interface computer due to power interruption.Discard samples in rack if rack is located on rsm transport¿.The screen then turned black, and the customer noted smoke from the back of the monitor.Power was turned off immediately.No other damage was noted.There were no reported injuries, impact to user safety, or impact to patient management.
 
Event Description
The customer reported smoke from the back of the monitor on the alinity ci-series system control module.The customer initially reported wz2 flush failed errors occurred and after a power cycle the monitor screen remained black when powering back up.When the computer was powered on with switch on the pc itself, it generated the following error 'aim=0274 | sub_aim= | improper shutdown on user interface computer due to power interruption.Discard samples in rack if rack is located on rsm transport¿.The screen then turned black, and the customer noted smoke from the back of the monitor.Power was turned off immediately.No other damage was noted.There were no reported injuries, impact to user safety, or impact to patient management.
 
Manufacturer Narrative
The alinity ci-series system control module, serial # (b)(6) was evaluated, and it was determined that alinity monitor and an electrical cable required replacement.It was noted that the smoke did not spread to other parts of the module.No additional discrepant result issues have been reported since.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional service tickets associated with the customer reported event.A review of tracking and trending did not identify a trend for the alinity monitor with regards to the customer reported event.A review of the manufacturing documentation did not identify any related non-conformances or potential non-conformances for the alinity monitor as it relates to the customer reported event.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified.
 
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Brand Name
ALINITY CI-SERIES SYSTEM CONTROL MODULE
Type of Device
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Manufacturer (Section D)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer (Section G)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18809331
MDR Text Key336738296
Report Number3016438761-2024-00125
Device Sequence Number1
Product Code JJE
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03R70-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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