MAUDE Adverse Event Report: ABBOTT LABORATORIES APS INPUT OUTPUT MODULE; DECISION MANAGER FOR ACCELERATOR

Catalog Number 07L01-51

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

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 heard an abnormal sound, smelled a burning odor and observed smoke coming from the acelerator aps system input/output module (aps iom) pc.The aps line was stopped.The customer was able to continue their workflow by loading the samples directly into the instruments.There was no impact to patient management, user safety, or facility damage reported.

Manufacturer Narrative

The field service representative (fsr) inspected the aps input/output module (iom) and determined the iom power supply as the likely cause of the incident.However, no evidence of burning or charring on the iom power supply was observed.The fsr replaced the part which resolved the issue.A review of tracking and trending did not identify any adverse trend with regards to the current issue.The current ticket is the sole complaint for the reported issue.The device history records were reviewed, and no non-conformances or potential non-conformances were identified for the iom power supply.Labeling was reviewed and found to be adequate.Further investigation was indicated by the manufacturer, inpeco.The investigation concluded that the automation system was installed in 2009 and the incident was likely the result of normal wear of old hardware (hw) components.No potential safety risks were identified.A review of the risk reduction for safety hazards memo indicates abbott diagnostic equipment and accessories are certified to the appropriate safety standards and the operator is protected against the spread of fire from the equipment.Based on the investigation, no systemic issue or deficiency of the aps input/output module serial number (b)(6) or the iom power supply was identified.

• Brand Name: APS INPUT OUTPUT MODULE
• Type of Device: DECISION MANAGER FOR ACCELERATOR
• 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 Key: 15150656
• MDR Text Key: 303343646
• Report Number: 3016438761-2022-00345
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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: 08/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07L01-51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 08/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1