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

Catalog Number 07L01-01

Device Problem Mechanical Problem (1384)

Patient Problem Head Injury (1879)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information is available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported multiple user injuries that occurred while using the aps iom.The customer reported that on (b)(6) 2021 a technician got hit on the head while trying to lift the cover to reset the line.The technician had a bump on the head and ice was applied.The customer stated that the technician had a big knot on the head for five days and experienced a headache for the rest of the night when injury occurred.No further treatment was necessary.The technician reports that subsequently they are feeling fine.Additionally, the customer reported that that during summer 2020 another technician experienced a finger pinch from a falling instrument lid.No treatment was necessary.No impact to patient management was reported.

Manufacturer Narrative

This follow up is submitted, to populate fields d8 and/or h6 with data, that had previously been provided in field h10.There is no change to the content of the data.

Manufacturer Narrative

H6 health effect impact code: f11.Component code: g03001.D8 was this device serviced by a third party? no.An investigation was performed for the accelerated processing system (aps) input/output module (iom), serial b)(6).Based on the information received, it was determined that the injury occurred on a monitor and not part of the automation module.The operator removed a lower panel and no associated gas springs or locking mechanism was associated with the panel.A review of tracking and trending for the aps iom (part number 07l01-01) did not identify any trends.Labeling was reviewed and found to be adequate.Use error may have contributed to the customer¿s issue as precautions were not observed when operating at or near the aps track system.Based on the investigation no systemic issue or deficiency of the aps iom (part number 07l01-01) was identified.

• Brand Name: APS INPUT OUTPUT MODULE
• Type of Device: DECISION MANAGER FOR ACCELERATOR
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11388815
• MDR Text Key: 239600745
• Report Number: 3016438761-2021-00065
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

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: 07L01-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 04/05/2021; 06/20/2021
• Supplement Dates FDA Received: 04/25/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1