MAUDE Adverse Event Report: RONDISH COMPANY LIMITED MONITOR, BED ALARM, AUTO RESET; MONITOR, BED PATIENT

Model Number	M2100-SL2
Medical Device Problem Code	Delayed Alarm (1011)
Health Effect - Clinical Codes	Depression (2361); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the nursing staff, the patient was oob (out of bed) and the bed alarm failed to alarm timely.When they heard the alarm, the patient was already on the floor.Thus, the staff feel that there was a delay in the alarm.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 11/22/2023 reporting according to the nursing staff, the patient was oob (out of bed) and the bed alarm failed to alarm timely.When they heard the alarm, the patient was already on the floor.Thus, the staff feel that there was a delay in the alarm.The sample has not been returned for evaluation at this time.A supplier corrective action request (scar) was issued to the bed alarm supplier smart caregiver.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.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 11/22/2023 reporting according to the nursing staff, the patient was oob (out of bed) and the bed alarm failed to alarm timely.When they heard the alarm, the patient was already on the floor.Thus, the staff feel that there was a delay in the alarm.The sample was not returned for evaluation.A supplier corrective action request (scar) was issued to the bed alarm supplier smart caregiver.The root cause was unable to be determined by the supplier smart caregiver.Due to the sample not being returned for evaluation.Due to no root cause being determined there were no corrective and preventive actions taken by smart caregiver.An inventory check of the monitor, bed alarm was made by deroyal, a total of (b)(4) of the m2100-sl2 were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: MONITOR, BED ALARM, AUTO RESET
• 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
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 18317876
• Report Number: 1060680-2023-00015
• Device Sequence Number: 6278798
• Product Code: KMI
• UDI-Device Identifier: 00749756980449
• UDI-Public: 00749756980449
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: M2100-SL2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/30/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown