MAUDE Adverse Event Report: RONDISH COMPANY LIMITED DEROYAL CHAIR SENSOR PAD

Model Number M220-CP

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

Patient Problem Fall (1848)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

This incident involves a chair sensor pad (b)(4) connected to patient alarm.The following was reported to deroyal: a patient was sitting in a wheelchair equipped with a sensor pressure pad (b)(4).The pressure pad was connected to an alarm monitor.According to the staff the alarm monitor was set to 0 second delay, therefore the alarm should have gone off as soon as the patient got up.Instead of the alarm going off after 0 seconds, there was a 4-5 second delay.This resulted in the patient falling off the wheelchair.The staff confirmed that delay was set on 0 and that all settings were correct.The chair sensor pad in question was collected and sent to deroyal for testing.The patient was reported to have had soreness from the fall and no other outcomes from incident.

Manufacturer Narrative

No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: DEROYAL CHAIR SENSOR PAD
• Type of Device: CHAIR SENSOR PAD
• Manufacturer (Section D): RONDISH COMPANY LIMITED; unit g & h, 4/f, block 1; 15-33 kwai tak st, kwai tak industrial centre; kwai chung ; HK
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653621013
• MDR Report Key: 4673988
• MDR Text Key: 5732020
• Report Number: 1060680-2015-00006
• Device Sequence Number: 1
• Product Code: EFQ
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M220-CP
• Device Catalogue Number: 69251
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2015
• Event Location: Hospital
• Date Manufacturer Received: 03/08/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other