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

Catalog Number 07L01-02

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Asthma (1726)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer expressed concern over the amount of aluminum dust created by the track belts on the aps iom.An employee passed out while working near the aps iom on (b)(6) 2015.The employee was seen in the er and later at occupational health where the occupational health physician recommended a workplace evaluation specifically of the aps due to exacerbation of the employee's asthma.A serious injury could not be ruled out, therefore this is an adverse event.There was no additional patient information provided.There was no additional patient impact reported.

Manufacturer Narrative

An evaluation was performed by reviewing the complaint text, review of other customer complaints for similar issues, a review of labeling, and a review of historical data.A review of service tickets for aps serial number (b)(4) did not show any other tickets for this issue.Abbott field service performs preventive maintenance approximately every 6 months which includes use of a vacuum cleaner with a 0.3 micron hepa filter to remove dust.A review of customer complaints received for this issue did not identify any trends or increased complaint activity for the aps.(b)(4) (third party manufacturer) indicated that dust formation was considered during product design and different solutions have been released and applied to reduce it.Safety shields and covers are present over the entire system and are to remain in place unless specifically instructed to remove them to perform certain procedures.A retrofit kit for placement of (b)(4) (stainless steel) strips on the aps has been implemented at the site to reduce exposure to dust generated by the system.A study commissioned by (b)(4) measured concentrations of different components of the track dust and all were found to be below permitted limits as established by (b)(6).Based on the available information, a deficiency of the system was not identified.There is insufficient information to reasonably suggest a device malfunction occurred.

• 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: 5383138
• MDR Text Key: 36520349
• Report Number: 1628664-2016-00015
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07L01-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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
• Patient Outcome(s): Required Intervention