MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS AFINION 2 ANALYZER

Model Number 1116772

Device Problems Smoking (1585); Sparking (2595); Unintended Electrical Shock (4018)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

21 nov 2023: technical services (ts) received a phone call from the customer stating that they were having an issue with their afinion 2 instrument.The customer reported the power cord sparked.The customer mentioned that he plugged the instrument into the wall socket and suddenly he noticed a spark and smelled burning, on the power supply he noticed burn marks, static electrical problem and electrical shock.The device was turned off when the problem occured.There was no injury to user, there was no delay in patient treatment and no patient impact.(b)(6) 2023: customer confirmed spark from wall outlet when connecting.Mascott power supply was used.The circuit breaker did not trip.(b)(6) 2023: customer confirmed by call, that no electrical shock impact happened.

Manufacturer Narrative

None.

• Brand Name: AFINION 2 ANALYZER
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; po box 6863 rodelokka; oslo N0-05 04; NO N0-0504
• Manufacturer Contact: claire dora ; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05-04 ; NO NO-0504 ; 24056000
• MDR Report Key: 18325031
• MDR Text Key: 330486343
• Report Number: 9613069-2023-00006
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K182988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/14/2023

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 Model Number: 1116772
• Device Catalogue Number: 1116772
• Device Lot Number: 10216669
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1