MAUDE Adverse Event Report: RONDISH COMPANY LIMITED NURSE CALL CORD, UNIVERSAL; MONITOR, BED PATIENT

Model Number	M2300-NC
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient successfully wrapped call light cord attached to inpatient bed around neck, causing cardiac arrest, code blue event.Patient was resuscitated and transferred to icu following event.
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2023 reporting a patient successfully wrapped call light cord attached to inpatient bed around neck, causing cardiac arrest, code blue event.Patient was resuscitated and transferred to icu following event.The sample is not available for evaluation.The root cause was determined to be end user error.Literature / catalog 0-2333 was reviewed and found to list the following warning: failure to comply with these warnings may result in injury or death.This device is not suitable for all individuals.This device is not a substitute for visual monitoring by caregiver.The manufacturer does not claim that this device will stop elopement and/or stop falls.This device is designed to augment caregivers' comprehensive patient mobility management program.Test this device before each use.Do not use without reading the instructions.These fall prevention devices are to be installed by a licensed caregiver.As such, it is the entire responsibility of the caregiver to ensure that the system is not designed to replace good caregiving practices including but not limited to: direct patient supervision, adequate training for staff personnel for fall prevention and/or elopement, and testing of the system before each use.An inventory check of the nurse call cord, universal was made by deroyal, a total of 13 of the m2300-nc were inspected, and no discrepancies were identified during the inspection.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: NURSE CALL CORD, UNIVERSAL
• Common Device Name: MONITOR, BED PATIENT
• Manufacturer (Section D): RONDISH COMPANY LIMITED; unit g & h, 4/f, blk 1; 15-33 kwai tak st.; kawi chung, nt, hong kong, hk, ; CH
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 hwy 33 south; new tazewell TN 37825
• MDR Report Key: 17452041
• Report Number: 1060680-2023-00008
• Device Sequence Number: 18015321
• Product Code: KMI
• UDI-Device Identifier: 00749756847711
• UDI-Public: 0749756847711
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: M2300-NC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown