MAUDE Adverse Event Report: NIHON KOHDEN AMERICA, INC. NIHON KOHDEN; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number CU-192R

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

Nihon kohden cardiac monitors purchased for entire hospital, icu now using these monitors.Multiple issues identified with oxygen sensors.Separate medwatch submitted on 09-20-23.Multiple issues with failure of blood pressure cuff where an error message occurs "unable to obtain" when a patient is hypotensive.Nihon kohden representatives have been informed but to date - no solution.Last evening blood pressure "unable to obtain" on critically ill patient.Staff had to obtain different equipment.On that monitor, patient's blood pressure 70's.Patient required medicine for hypotension.Initiating the medicine was delayed as staff needing to get different equipment.Time (12:48), nk cuff (81/60), zoll cuff (119/75).Time (12:50), nk cuff (156/60), zoll cuff (143/92).Time (12:52), nk cuff (156/60), zoll cuff (176/91).Time (12:56), nk cuff (106/72), zoll cuff (106/72).Time (12:58), nk cuff (unable to obtain), zoll cuff (75/54).Time (12:59), nk cuff (unable to obtain), zoll cuff (78/57).Time (13:00), nk cuff (unable to obtain), zoll cuff "(82/52)".

• Brand Name: NIHON KOHDEN
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): NIHON KOHDEN AMERICA, INC.
• MDR Report Key: 17949583
• MDR Text Key: 326007882
• Report Number: MW5147019
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Model Number: CU-192R
• Device Catalogue Number: (01) 04931921112168 (21) 08865
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White