MAUDE Adverse Event Report: J. T. POSEY CO. SITTER ELITE; KMI

Model Number 8345

Device Problem Improper Alarm (2951)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported the plastic connector to the nurse call outlet is missing and when the nurse call cable is plugged into the receptacle, the nurse call is sounding inconsistently at the nurse's station.The customer reported this was discovered during use however the customer could not provide the date of the event.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned product found the connector is not missing on the nurse call outlet of the alarm; however, it is loose.When the customer's nurse call cable is plugged into the receptacle and the cable is moved, the nurses call light toggles on and off.When the alarm is tested with a known working nurse call cable, the nurse call light does not come on.The alarm passes all other functional testing.There are cracks on the dust covers outside the battery compartment.The warning label is peeled off.There are scrapes on the front and back enclosures.See manufacture report 2020362-2014-00302 for nurse call cable report.(b)(4).

• Brand Name: SITTER ELITE
• 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: 4101979
• MDR Text Key: 4756131
• Report Number: 2020362-2014-00301
• 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: 8345
• Device Catalogue Number: 8345
• 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: 10/01/2011
• 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: NURSE CALL CABLE: MODEL 8282, LOT #N1150