MAUDE Adverse Event Report: J. T. POSEY CO. NURSE CALL CABLE /W ADAPTER

Model Number 8235NCS

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

The customer reported the nurse call cables are not sending a signal to the nurse call station.The date when the issue was discovered is unk.Customer provided limited info.No pt incident or serious injury reported.

Manufacturer Narrative

Results: eval of the returned seven nurse call cables revealed that six cables pass the functional tests and only one cable did not pass functional tests.The cable y connector right socket functions as expected.However, the left socket is loose and when tested, the nurse call led did not come on at the nurse call test fixture when weight was removed from the sensor pad.Opened the adapter cover and observed a broken wire, after the wire was re-solder the nurse call worked as expected.(b)(4).

• Brand Name: NURSE CALL CABLE /W ADAPTER
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: mary sagura ; 5635 peck rd.; product surveillance dept; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3770350
• MDR Text Key: 16779858
• Report Number: 2020362-2014-00044
• 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
• Type of Report: Initial
• Report Date: 11/05/2013

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: 8235NCS
• Device Catalogue Number: 8235NCS
• Device Lot Number: 3064A25
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ALARM SITTER ELITE, PN 8345, SERIAL # UNK