RAULAND RESPONDER-5 * 2S16

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-20 for RAULAND RESPONDER-5 * 2S16 manufactured by Curbell Medical Products, Inc..

Event Text Entries

[4003425] This facility has had multiple and regular instances were patients try to use the nurse call system and the nurse is unable to hear the patient. The patient activates the call light system, but the nurse is not notified. The staff are unable to hear the patient. We continue to send the hand held device back to the company. The company reports that a specific part within the call light is breaking (part number 41414u-101393a). These are pillow speakers, typically used by patients who do not have use/control of their extremities or who are non-verbal. The call light is activated by the patient turning their head onto the device. Staff test the device when it is first installed in the patient room and the device appears to be working (the call light system activates). However, during the course of care, the call light breaks. There is no warning or signal that the device has broken. The call light system itself was installed in 2009. ) there has not been patient harm; however, there is increased risk of patient harm because the nursing staff are not alerted to a patient's need when the call light system is not functioning. Facilities staff estimate that one device or more per month has been returned to the manufacturer. The manufacturer has not been able to provide a reason for the problem: the part is replaced and the device is returned to the facility.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3483017
• MDR Report Key: 3483017
• Date Received: 2013-11-20
• Date of Report: 2013-10-28
• Date of Event: 2013-09-16
• Report Date: 2013-10-28
• Date Reported to FDA: 2013-11-20
• Date Reported to Mfgr: 2013-11-22
• Date Added to Maude: 2013-11-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RAULAND RESPONDER-5
• Generic Name: SYSTEM, COMMUNICATION
• Product Code: ILQ
• Date Received: 2013-11-20
• Model Number: *
• Catalog Number: 2S16
• Lot Number: *
• ID Number: *
• Operator: PATIENT
• Device Availability: Y
• Device Age: 2 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CURBELL MEDICAL PRODUCTS, INC.
• Manufacturer Address: 20 CENTRE DRIVE ORCHARD PARK NY 14127 US 14127

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-11-20