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 Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.(b)(4).See manufacturer report number 1628664-2016-00105 for the second patient.

Event Description

The customer reported two employees who experienced respiratory issues due to dust on the aps.The customer is having the 2 affected employees wear an n95 respirator mask if they have to be scheduled in that area.The customer is concerned the dust is causing their staff to become sensitized so that even small amounts of exposure could cause a reaction.She was seen by employee health on 4.8.16 with hoarseness and shortness of breath.No treatment was given only avoidance of the working area, until a follow up appointment can be scheduled.

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 investigations.No adverse trend was identified for the customers issue and no other customers have reported dust.Labeling was reviewed and found to be adequate.The dust components were identified as aluminum and zinc as the primary dust constituents from the analysis.The customer indicated that the ventilation system was evaluated and was functioning properly, all vents were cleaned and inspected.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 study measured concentrations of different components of the track dust, all were found to be below permitted limits as established by the american conference of governmental industrial hygienists.Additional measures besides the covers and shields cited above are in place to reduce exposure to dust generated by the system.Preventive maintenance (pm) is performed every 6 months which includes utilization of a vacuum cleaner with a 0.3 micron hepa filter to remove dust.Steel strips were installed on the system and testing showed that the application of the steel strips mitigates the creation of dust.Based on all available information and abbott diagnostics' complaint investigation, the device performed as intended and no product deficiency was identified.

Manufacturer Narrative

The conclusion code was corrected.The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or 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: 5627862
• MDR Text Key: 44304815
• Report Number: 1628664-2016-00104
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2017

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: 04/11/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/23/2016; 04/23/2017
• 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): Other