MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC APS TUBE STORAGE MODULE; STORAGE MODULE FOR ACCELERATOR

Catalog Number 07L07-52

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2017

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 seeing a spark (white light) from the srm compressor housing vents on the accelerator automated processing systems (aps).There was no report of smoke, fire or injury.

Manufacturer Narrative

Date received by manufacturer) was incorrect.The date is being changed from 12/07/2016 to 12/07/2017.

Manufacturer Narrative

The customer reported seeing a spark from the accelerator automated processing system (aps) tube storage module (srm) compressor housing vents.The field service representative (fsr) removed the housing to inspect the compressor and did not find any issues or evidence of spark/arcing originating from the unit.No evidence of smoke, fire or injury was reported.The accelerator automated processing systems operations manual was reviewed and was found to adequately address the issue.Operational precautions, limitations and hazards regarding electrical safety when working with the accelerator aps workcell are provided.Customer complaint data was reviewed and did not identify any issues or adverse trends on the accelerator aps tube storage module.Based on the available information no product deficiency of the accelerator aps tube storage module was identified.

• Brand Name: APS TUBE STORAGE MODULE
• Type of Device: STORAGE MODULE 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: 6988551
• MDR Text Key: 91197290
• Report Number: 1628664-2017-00405
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2018

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: 07L07-52
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 12/07/2016; 02/02/2018
• Supplement Dates FDA Received: 01/02/2018; 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1