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

Catalog Number 07L01-01

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed sparks on the aps.The customer observed the robot arm was moving left to read the racks, a snap and sparks were heard.Sparks were also observed.There were no injuries.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.The customer was cleaning the rail when the robot arm moved to read the racks.A snap and a spark were heard and observed.The field service representative found the iom robot operational and paused to inspect the assembly.The issue was resolved by replacing the y axis motor and cable (part number 8-207595-01).No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: APS INPUT OUTPUT MODULE
• Type of Device: DECISION MANAGER FOR ACCELERATOR
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 8549698
• MDR Text Key: 143070612
• Report Number: 1628664-2019-00338
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07L01-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 06/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1