MAUDE Adverse Event Report: BOULE MEDICAL AB MEDONIC M-SERIES

Model Number 1400074

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/07/2020

Event Type  Injury  

Event Description

Clinical diagnostic technical support employee received a call on (b)(6) 2020 from (b)(6), the lab contact (b)(6) medical center in (b)(6) with an issue on their m-series medonic, serial # (b)(4).She noticed in the morning the analyzer, which is powered on 24/7, had no power.The office manager, (b)(6) assisted with the inspection as to why and experienced a mild shock when picking up the ac/dc adaptor that was found in a puddle of fluid.(b)(6) did not suffer any significant injury from the shock.After picking up the power supply with gloved hands, (b)(6) disconnected the main power cable from the wall mounted power outlet.Upon inspection (b)(6) discovered the lyse line from the analyzer to the sink drain was disconnected at the analyzer.At the time, the cause of the disconnection was unknown.The spill was collected, and customer was informed to follow facilities standard operational procedures for cleanup.Customer was instructed to not power up the analyzer until the service visit for inspection and potential repairs.It was recommended that dorothy inform the medical director, dr.(b)(6) of the incident.On 10/09/2020, cds service representative was on site for evaluation and repairs and spoke to (b)(6) to recapped the occurrence.She stated that she was told that there was a leak and no power to the analyzer and attempted to move the analyzer and reinsert the lyse pickup tube.She was not wearing any ppe at time and felt a mild shock.She contacted cds and was advised to seek medical attention.She did seek medical attention and was fine with no side effects or treatment given.She then got ppe and reinserted the lyse pickup tube and powered off analyzer.Cds service representative cleaned up all spill residue installed a new power supply.Based on the placement of the analyzer, customer was advised to relocate analyzer to different location with more room but refused.As a courtesy, cds service installed new pick up tubes with longer silicone sleeve and secured them with zip ties and secured them to back splash.In addition, he rerouted pickup tubes between analyzer and reagent box the analyzer was powered on and both qc and reproducibility passed.Customer satisfied with response.There was no death or serious injury.There was no exposure to mucous membranes or open wounds.There was no evidence of charring, burning or flames.Labeling advises that if a leak is observed to disconnect the main power supply immediately by pulling out the cord from the main supply.The power supply is ul listed.

• Brand Name: MEDONIC M-SERIES
• Type of Device: MEDONIC M-SERIES
• Manufacturer (Section D): BOULE MEDICAL AB; domnarvsgatan 4; se-163-53; spagna, sw, ; SW
• MDR Report Key: 10726144
• MDR Text Key: 216001961
• Report Number: 1064130-2020-00001
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1400074
• Device Catalogue Number: 1400074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/07/2020
• Device Age: 9 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other