MAUDE Adverse Event Report: RONDISH COMPANY LIMITED DEROYAL; MONITOR, BED PATIENT

Model Number	M2200-CP-CS2
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Chair sensor pad for chair alarm for fall precautions are noted to fail when the patient stands and the alarm does not go off.Chair sensor pad and connectivity point to the portable chair alarm box appropriately engaged, batteries are ok.Testing with a new chair pad to the chair alarm box works well.Additionally, if chair sensor pad gets wet from incontinence through incontinence pads on the chair (over the chair sensor pad), the chair sensor will also not work.
Additional Manufacturer Narrative
A user facility medwatch report (# (b)(4)) was received reporting the chair sensor pad for chair alarm for fall precautions are noted to fail when the patient stands, and the alarm does not go off.Additionally, if chair sensor pad gets wet from incontinence through incontinence pads on the chair (over the chair sensor pad), the chair sensor will also not work.There was no injury reported.The sample has not been received for evaluation.A supplier corrective action request (scar) was issued to 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
Root cause: the actual sample has not been returned for evaluation.Therefore, smart caregiver was unable to determine the true root cause.Smart caregiver has determined that excessive moisture can damage the pad.Corrective action: a corrective action has not been taken due to the root cause determination.An inventory check was made by deroyal, a total of 50 m2200-cp-cs2 sensor pads were inspected, and no functional 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: DEROYAL
• 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: 12976455
• Report Number: 1060680-2021-00006
• Device Sequence Number: 11950299
• Product Code: KMI
• UDI-Device Identifier: 00749756980456
• UDI-Public: 0749756980456
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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 Model Number: M2200-CP-CS2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown