MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP STORAGE RIGHT; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06T13-01

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During installation of the glp system, it was noted that the module was not responding to any communication.During troubleshooting, a burning smell was noted, and a short circuit was found on the board.When the board was removed, the field service engineer noticed evidence of smoke/burn on the board and on the housing where the board was mounted to the board circuit.No impact to user safety / patient management was reported.

Manufacturer Narrative

During installation, the field service representative (fsr) reported a first use failure (fuf) of the base board achive ii -2.After turning on module, the error, 21437 storage init failed, was displayed and the fsr smelled something burning.Upon further investigation, the fsr found the base board achive ii -2 had no power and there was evidence of smoke/burn marks on the board.No injury was reported and no visible smoke, fire, or sparks were observed.Trending review did not identify any trends for the issue under review.Labeling review concludes that the issue is adequately addressed.Based on the investigation, no deficiency was identified.

• Brand Name: GLP STORAGE RIGHT
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer (Section G): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16593769
• MDR Text Key: 311795455
• Report Number: 3023268435-2023-00013
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K213486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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: 06T13-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BASE BOARD ACHIVE II -2, G-41628-01, UNKNOWN; BASE BOARD ACHIVE II -2, G-41628-01, UNKNOWN