MAUDE Adverse Event Report: DEROYAL COMPANY LTD UNIT G & H DEROYAL; SAFETY AUTO-RESET FALL ALARM MONITOR

Model Number M2100-S

Device Problems Invalid Sensing (2293); Decreased Sensitivity (2534); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

The (sensor pad) alarm was delayed before sounding off.The care giver realized this once the pt was taken from the chair.It raised concerns because if the alarm is not working properly it could potentially result in an incident in the future.No injury happened to the pt.

Manufacturer Narrative

Investigation findings: the alarm monitor was returned, with batteries (the pad that was also requested, but was not returned.) investigation pulled a new pad from stock and hooked up the returned monitor.When the pad is plugged into the monitor the "pad lost" light goes off.When pressure is added to the pad the monitor beeps twice and the "monitor status" light blinks indicating that the pad is in use, as soon as pressure is lifted the alarm sounds.To silence the alarm, the reset button is pressed.Investigator was able to test the monitors function several times, with no issues found, the alarm was immediate every time pressure/weight was lifted.Without the pad being returned, there is no way to determine if the pad could have been issue, and not the alarm.Correction: none required.Root cause analysis: the alarm was tested several times, the alarm sounded immediately, without failure.No defect was found.Corrective action and/or systemic correction action taken: no action required at this time, no vendor/mfg issue was found.

• Brand Name: DEROYAL
• Type of Device: SAFETY AUTO-RESET FALL ALARM MONITOR
• Manufacturer (Section D): DEROYAL COMPANY LTD UNIT G & H; 15-33 kwai tak st, 4/f, block 1, kwai tak; industrial centre; kwai chung, hong kong ; HK
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653621013
• MDR Report Key: 4762401
• MDR Text Key: 5797960
• Report Number: 1060680-2015-00034
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2015

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: M2100-S
• Device Catalogue Number: 80844
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other