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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
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ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Back to Search Results
Catalog Number 03R65-01
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2023
Event Type  malfunction  
Event Description
Abbott technical support observed sparks coming from the vacuum pump on the alinity i processing module while troubleshooting vacuum errors.The module was powered down for service.Both vacuum pumps were replaced to resolve the issue.No fire, smoke or injury was reported.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
The field service representative (fsr) reported seeing sparks coming from the vacuum pump on the alinity i serial # (b)(6) due to a bad electrical contact.The fsr replaced the pump which resolved the issue.The instrument service history review for (b)(6) revealed no additional issues of sparks.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i processing module, serial (b)(6) or the vacuum pump was identified.
 
Event Description
Abbott technical support observed sparks coming from the vacuum pump on the alinity i processing module while troubleshooting vacuum errors.The module was powered down for service.Both vacuum pumps were replaced to resolve the issue.No fire, smoke or injury was reported.
 
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Brand Name
ALINITY I PROCESSING 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
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key17577351
MDR Text Key321636646
Report Number3016438761-2023-00429
Device Sequence Number1
Product Code JJE
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 09/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03R65-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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