MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) APS DECAPPER; DECAPPER FOR ACCELERATOR

Catalog Number 07L03-01

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2020

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 the robotic head of the aps decapper was hot to the touch and emanated smoke.No injuries occurred due to this issue.No impact to patient management was reported.

Manufacturer Narrative

During the subsequent site visit by the field service engineer (fse) the analyzer was inspected and discovered that the aps decapper module motor was not functioning due to a failed relay.Both the motor and the relay were replaced by the fse which resolved the issue.A review of the service history for the aps decapper module revealed no additional issues were reported.A review of tracking and trending did not identify any trends for the aps decapper module or the motor and relay.Labeling was reviewed and contains adequate information on troubleshooting, removal and replacement of the parts and for basic electrical hazards.The parts were discarded so the investigation was unable to determine cause of the issue.Based on the investigation, no product deficiency was identified.

• Brand Name: APS DECAPPER
• Type of Device: DECAPPER FOR ACCELERATOR
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9989969
• MDR Text Key: 188634902
• Report Number: 3016438761-2020-00049
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

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: 07L03-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1