MAUDE Adverse Event Report: ABBOTT LABORATORIES ACCELERATOR APS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 07L32-51

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account stated the accelerator aps spur is smoking and requested field service.Initially, the account stated there was a noise of unspecified source coming from the track.The account stated there were no errors, no physical obstruction, and no observed issues.No injury was reported.

Manufacturer Narrative

Section g.1 contact name, address, phone, fax, email updated.The customer reported the spur motor part was replaced on (b)(4)2021.The customer later reported noise on the track.No errors, physical obstructions or issues were reported.While awaiting a response from field service engineer, the customer observed smoke from the spur of the aps i2sr interface module.The field service engineer (fse) dispatched to the customer site, did not find any evidence of smoke or burning.It was likely the motor kept turning the belt in the drive assembly; while the gears were locked.This likely caused the belts to create a burning smell.However, this could not be confirmed.The origin of smoke reported by the customer was unknown.The fse replaced the motor, micrometers e192.24.49 and drive assembly on (b)(4)2021.No further incidents were reported.The investigation did not identify a replacement frequency or potential safety risks associated with the parts.In addition, historical data did not contain any record of similar issues.Therefore, no deficiency was identified for the motor, micrometers e192.24.49 or the motor belt, im group.It was concluded that the burning smell was likely the result of a hardware failure.Current labelling provides adequate troubleshooting, replacement and verification procedures in case of hardware malfunctions.In addition, it describes potentially hazardous conditions and provides the operator with precautions and safety measures to minimize or avoid personal injury or damage to the work cell while it is in operation.A review of tickets for similar for related issues to the current complaint did not identify any adverse trends.No adverse trends for the aps i2sr interface module (im) related to the current issue.Current ticket is the sole complaint for the reported issue.A search within corrective and preventative action system did not find a non-conformance or potential non-conformance for replaced parts.No systemic issue or product deficiency was identifiedsection g.1 contact name, address, phone, fax, email updated.

Manufacturer Narrative

Upon further review on 06/06/2022, it was discovered that mfr report 3016438761-2021-00492-01 inavdertantly entered the incorrect year for section g3.Date received by mfg of 04/07/2021.The correct date received by mfg should have been 04/07/2022.Upon further review on 06/06/2022, it was discovered that mfr report 3016438761-2021-00492-01 inavdertantly entered the incorrect year for section g3.Date received by mfg of 04/07/2021.The correct date received by mfg should have been 04/07/2022.

• Brand Name: ACCELERATOR APS
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12856430
• MDR Text Key: 281111176
• Report Number: 3016438761-2021-00492
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093318
• 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,Followup
• Report Date: 06/06/2022

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: 07L32-51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 04/07/2021; 06/06/2022
• Supplement Dates FDA Received: 05/04/2022; 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1