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

Model Number 8282

Device Problem Improper Alarm (2951)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported the nurse's station sounds inconsistently when the alarms are in use with the nurse call cables.This was discovered during use; however, the customer could not provide the date of the event.No pt incident or injury was reported.

Manufacturer Narrative

Results: eval found that the customer returned two nurse call cables from this same lot number.The first cable was tested with a known good alarm and the nurse call indicator light at the nurse call test fixture toggles on the off when the nurse call cable is wiggled.When the nurse call cable was opened up.It was found to have a broken ground wire.The second cable was tested with a known good alarm and was found not to turn on and off at the nurse call test fixture.When the nurse call cable was opened up, it was found to have a broken ground wire.Both cables have scuff marks on them and one of the nurse call jacks on loose on one cable.(b)(4).

• Brand Name: NURSE CALL CABLE
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: pam wampler ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4101985
• MDR Text Key: 4756658
• Report Number: 2020362-2014-00307
• 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: Unknown
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8282
• Device Catalogue Number: 8282
• Device Lot Number: N1147
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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 MODEL SITTER ELITE: SN UNK