MAUDE Adverse Event Report: RESPIRONICS, INC. ACTIWATCH SPECTRUM PLUS; SYSTEM, ISOKINETIC TESTING AND EVALUATION

Model Number	1101894
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the device port was damaged while being charged.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for evaluation.During the evaluation, the manufacturer observed that device was damaged with the case melted at the usb port.They are unable to confirm how damage occurred and unable to repair the device.The device was scrapped and replaced under warranty.

• Brand Name: ACTIWATCH SPECTRUM PLUS
• Common Device Name: SYSTEM, ISOKINETIC TESTING AND EVALUATION
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18027830
• Report Number: 2518422-2023-27990
• Device Sequence Number: 6833876
• Product Code: IKK
• UDI-Device Identifier: 00606959021440
• UDI-Public: 00606959021440
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 1101894
• Device Catalogue Number: 1101894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown