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

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 alarm is in use with the nurse call cable.Customer reported this was discovered during use, but could not provide the date of event.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned nurse call cable and alarm found that when the customer's nurse call cable is plugged with the unit, the unit does not send a signal to activate the red led at the nurse call test fixture.When the nurse call cable is tested with an in-house 8345 alarm, the cable does not send a signal to activate the nurse call light.The ground wire is broken inside the nurse call cable.No physical damage to the outside of the cable found.See manufacturer report # 2020362-2014-00301 for the alarm report.(b)(4).

• Brand Name: NURSE CALL CABLE
• Type of Device: KMI
• 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: 4101980
• MDR Text Key: 16083918
• Report Number: 2020362-2014-00302
• 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: Health Professional
• 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: N1150
• 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: 12/01/2011
• 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: SITTER ELITE: MODEL 8345, SN: (B)(4)