MalfunctionIKK
ACTIWATCH SPECTRUM PLUS
Received Oct 30, 2023 · Event occurred Mar 22, 2023
Report 2518422-2023-27990 · MDR key 18027830
Device
Generic name
System, Isokinetic Testing And Evaluation
Manufacturer
Respironics, Inc.Model number
1101894Catalog number
1101894
Product problems
- Melted
- Melted
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.