1 of 3 reports.Other mfg report numbers:
3013886523-2024-00040
3013886523-2024-00041
a facility reported a cerelink sensor (id 826851) had very high pressure (300), and then a flat line was seen five hours after placement.The sensor was removed and replaced.The second sensor worked for 11 hours, then suddenly, flat line.It was explanted and monitoring stopped.The sensors were connected to directlink module (id 826828).
|
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Cerelink sensor was returned for evaluation: dhr - lot 6896058 (sn (b)(6)), met specifications when released.Failure analysis - the issue of the complaint has been confirmed: - catheter nylon stretched in multiple areas.- catheter internal wires are broken.- icp express read ¿no transducer detected¿.- no testing possible.Root cause - based on the failure analysis, the root cause could be determined as a mishandling of the catheter.
|