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

Model Number BSM-6000

Patient Problems Bruise/Contusion (1754); Eye Injury (1845); Laceration(s) (1946)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

Patient was actively seizing when care team was attempting to attach telemonitor leads to the patient.Upon moving the leads, the transport module portion of the telemonitor fell out of its mounting location and fell onto the patient.This caused a laceration and a black eye.Manufacturer response for tele monitor transport module, life scope (per site reporter).Unknown what response is at this time.

• Brand Name: LIFE SCOPE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): NIHON KOHDEN AMERICA, INC.; 15353 barranca pkwy; irvine CA 92618
• MDR Report Key: 17885032
• MDR Text Key: 325078957
• Report Number: 17885032
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2023

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: BSM-6000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2023
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Weight: 52 KG