SPIDERFLASH
Received Oct 29, 2025 · Event occurred Sep 29, 2025
Report 1000165971-2025-00691 · MDR key 23413717
Device
Generic name
Electrocardiograph,ambulatory(without Analysis)
Model number
SPIDERFLASH-TProduct problems
- Loss of Data
- Loss of Data
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORTEDLY, THE DEVICE WAS CONNECTED AND WORKING DURING THE FULL 7 DAYS, HOWEVER NO ECG WAS RECORDED. THE CLIENT WANTS TO KNOW BASED ON THE FILES IF THE DEVICE MIGHT HAVE A PROBLEM. MEANWHILE THEY PERFORMED A QUICK 10 MIN TEST AND ALL SEEMS NORMAL. THE DEVICE WILL BE USED AGAIN.
Description of Event or Problem
REPORTEDLY, THE DEVICE WAS CONNECTED AND WORKING DURING THE FULL 7 DAYS, HOWEVER NO ECG WAS RECORDED. THE CLIENT WANTS TO KNOW BASED ON THE FILES IF THE DEVICE MIGHT HAVE A PROBLEM. MEANWHILE THEY PERFORMED A QUICK 10 MIN TEST AND ALL SEEMS NORMAL. THE DEVICE WILL BE USED AGAIN.
Additional Manufacturer Narrative
BASED ON THE ATTACHED FILES, THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE DEVICE WAS MANUFACTURED IN 2018, SO IT COULD BE A PROBLEM RELATED TO ONE OF THE ELECTRONIC BOARDS, BUT THIS DOES NOT APPEAR IN THE ATTACHED FILES. IF THE REPORTED PROBLEM RECURS, I RECOMMEND THAT YOU SEND THE DEVICE TO THE REPAIR CENTER SO THAT THEY CAN PERFORM A FUNCTIONAL AND RECORDING TEST. PLEASE LET ME KNOW IF YOU WANT ME TO DO IT NOW.