MAUDE Adverse Event Report: NIHON KOHDEN AMERICA, INC.; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number ORG-9110A

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was discovered on [date redacted] at 13:02 that the arrhythmia recall was not recording or updating on cardiac monitors.Then on [date redacted] at 11:04, we were notified that prefense was not storing non-invasive blood pressure (nibp) readings.Last evening, [date redacted], notified that prefense was not storing any information.After reboot the issue was corrected, but the device was still not saving nibp readings.Made nihon kohden aware on [date redacted] of issues related to the wmts digital telemetry receiver system.The manufacturer was also updated on [date redacted] related to prefense issues.Followed up with them multiple times.Learned that this is a nationwide issue, and that it will require a software update that they need to build.The company report that they are working on it but will still be several weeks.They did provide a work around to this in the interim but it is cumbersome and not ideal for the folks using the system or working with and monitoring the patients.

• Brand Name: NA
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): NIHON KOHDEN AMERICA, INC.; 15353 barranca pkwy; irvine CA 92618
• MDR Report Key: 11257779
• MDR Text Key: 229655625
• Report Number: 11257779
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2021
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1