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

Model Number	M2100-SL
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A call/complaint was received indicating the "patient slid to the floor and the alarm did not sound".There were no injury reported.The work order could not be reviewed because the finished good lot number was not reported.The sample was received and evaluated by quality control.A supplier corrective action request (scar) has been issued to the manufacturing facility.The sample has been returned to the manufacturing facility for further examination.This investigation is ongoing at this time.We will provide a follow up report when additional information becomes available.
Event or Problem Description
Quality issue details.Date of occurrence: (b)(6) 2018.When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? health professional.Was a medical procedure involved? no.Name of medical procedure: not applicable, did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: the alarm was used for a patient and the rn reported using the normal process.The patient slid to the floor and the alarm did not sound.When the alarm was tested later it seemed to work appropriately.The rn is certain that the alarm had been properly set and had malfunctioned.How was the quality issue was identified? by actual use.How was the product being used? used to monitor patients at risk of falling out of the chair.Was it the initial use of the product? no.Was the product modified from the original condition supplied by deroyal? no.Was the product connected to or used in conjunction with other devices or equipment? yes.Please describe connected equipment type, settings, etc.: used with our chair sensor (m2200-cp) has the end user notified the manufacturer of the other devices used in conjunction with or connected to the product? yes.Outcome details.Outcome(s) attributed to quality issue: none.Person(s) affected by outcome(s) checked above: none.Known pre-existing condition(s) of person(s) affected: none.Was the incident reported to the fda? no.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: none.
Additional Manufacturer Narrative
The supplier corrective action request (scar) response was received from smart caregiver corporation.The sample was evaluated and it was determined when pressure was applied on pad it alerted the monitor which alarmed as designed.The root cause could not be determined per the manufacture, because the product worked as designed during the evaluation.Corrective action has not been taken due to the root cause determination.Between, january 1, 2017 - february 19, 2019 there have been a total of 18 complaint reports for a percentage of 0.05483% units sold, of this product m2100-sl monitor, bed alarm, latching alarm.The investigation is complete at this time.We will provide a follow up report if additional information becomes available.

• Brand Name: DEROYAL
• Common Device Name: BED PATIENT MONITOR
• Manufacturer (Section D): RONDISH COMPANY LIMITED; unit g & h,4/f, blk 1; 15-33 kwai tak st.; kawi chung nt, china ; HK
• MDR Report Key: 8212375
• Report Number: 1060680-2018-00011
• Device Sequence Number: 19329617
• Product Code: KMI
• UDI-Device Identifier: 00749756878708
• UDI-Public: 00749756878708
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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
• Operator of Device: Health Professional
• Device Model Number: M2100-SL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1