MAUDE Adverse Event Report: HARMONIC BIONICS INC. HARMONY SHR; UPPER EXTREMITY ROBOTIC REHABILITATION DEVICE

Model Number	M1-00001
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected component is being sent to harmonic bionics from the distributor for evaluation and further investigation.As a precaution, communication was sent to other customers on (b)(6) 2024 to alert them of the potential for malfunction.This is harmonic bionics' first emdr submission.As a result, the report was delayed due to the signup process.This statement is per guidance from (b)(6).
Event or Problem Description
During a product demonstration, the customer engaged the mechanical emergency stop on the device and observed the presence of smoke in the rear enclosure.No user/patient was in the device during the demonstration.

• Brand Name: HARMONY SHR
• Common Device Name: UPPER EXTREMITY ROBOTIC REHABILITATION DEVICE
• Manufacturer (Section D): HARMONIC BIONICS INC.; 1807 w braker ln.; ste c-500; austin TX 78758
• Manufacturer (Section G): HARMONIC BIONICS INC.; 1807 w braker ln.; ste c-500; austin TX 78758
• Manufacturer Contact: mark hunter ; 1807 w braker ln.; ste c-500; austin, TX 78758 ; 5122223083
• MDR Report Key: 18920917
• Report Number: 3019887527-2024-00001
• Device Sequence Number: 14985171
• Product Code: IKK
• UDI-Device Identifier: 00850039266003
• UDI-Public: (01)00850039266003(11)240104
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: M1-00001
• Device Catalogue Number: A1-00-0000-00
• Device Lot Number: 2401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown