MAUDE Adverse Event Report: DRUCKER DIAGNOSTICS, LLC DRUCKER DIAGNOSTICS; HORIZON 6FA CENTRIFUGE, REGEN LAB

Model Number	00-276-088-001
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation pending the return of the suspect device.No findings could be determined at this time due to the device not yet being returned for investigation.Update will be pursued should the situation change accordingly.
Event or Problem Description
Nurse electrified, burned on the arm and hospitalized, in a work stoppage.No additional information has been provided by the customer or the injured party at this time.
Additional Manufacturer Narrative
Current investigation findings can be reviewed in the attached document "findings on rma 11312".Electrical component failure identified, as well as degradation of device housing, but no electrically conductive path could be identified to the outside of the housing that would affect the user.
Event or Problem Description
Nurse electrified, burned on the arm and hospitalized, in a work stoppage.No additional information has been provided by the customer or the injured party at this time.

• Brand Name: DRUCKER DIAGNOSTICS
• Common Device Name: HORIZON 6FA CENTRIFUGE, REGEN LAB
• Manufacturer (Section D): DRUCKER DIAGNOSTICS, LLC; 200 shady lane; suite 170; philipsburg PA 16866
• Manufacturer (Section G): DRUCKER DIAGNOSTICS, LLC; 200 shady lane; suite 170; philipsburg PA 16866
• Manufacturer Contact: joshua crouse ; 200 shady lane; suite 170; philipsburg, PA 16866 ; 8146927661
• MDR Report Key: 19054017
• Report Number: 3011765035-2024-00001
• Device Sequence Number: 8120439
• Product Code: JQC
• UDI-Device Identifier: 00810052862293
• UDI-Public: 00810052862293
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00-276-088-001
• Device Catalogue Number: 00-276-088-001
• Device Lot Number: 044313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown