MAUDE Adverse Event Report: JT POSEY COMPANY SITTER ELITE; FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED

Model Number 8345

Device Problem Low Audible Alarm (1016)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Product was requested to be returned for evaluation and has not been received.Additional information received found that the reported alarm has remained in use at the facility after the incident was reported.Further, the alarm was placed behind a chair and it was reported that the site often closes the door to the patient's room.Both of these factors could muffle the volume of the alarm and make it sound lower to caregivers not in the patient's room.Additionally, the site elected not to use the alarm with the nurse call cable to alert the nurse's station to any patient exit.Without the return of the alarm and with the limited information reported, there is not enough information to suggest that the alarm malfunctioned.The product instructions state: "test the alarm and sensor for proper operation prior to putting in service with a patient, and each time before leaving the patient unattended.If the alarm and/or sensor do not function properly, remove the alarm and sensor from service and replace them with a properly functioning alarm and/or sensor.Ensure the green led, indicating mode, is blinking and the red hold/suspend led is no longer flashing red." in addition, the ifu warns the user to "always check to ensure staff can hear alarm at the furthest possible distance before leaving patient unattended.All volume settings are within osha standards.For maximum staff alert in noisy areas, use highest (loudest) volume setting." note: this report is based solely on the customer reported issue that a patient fell and passed away.The male patient was in use with a posey alarm and chair sensor.Posey is continuing to investigate this incident and will provide additional information as it becomes available.(b)(4).

Event Description

Customer reported that one of the patients at the facility was in use with the posey sitter elite alarm and chair sensor and the nurse did not hear the alarm sound due to the default volume (medium) of the alarm being too low.The patient got out of the wheel chair and fell.The patient had internal bleeding in his head as a result of the fall and has passed away.

Manufacturer Narrative

Exhaustive attempts have been made to retrieve the alarm but the alarm could not be obtained for evaluation.An in-service was performed by posey at the hospital, at which point the alarm was found to have remained in use, after the reported incident.The in-service representative found the alarm in working condition and at the time of inspection the alarm was also chirping with a low battery warning.The product ifu states "do not allow batteries to deplete while in the alarm.Change batteries immediately when hearing the low battery ¿chirp.¿ depleted batteries may leak and corrode, causing damage to the electronics and reliability.When storing the alarm for a short period with power ¿on¿ to maintain custom voice messages and settings, check the alarm every week to make sure the batteries are still operable and the alarm is still on.If the alarm low battery alert is chirping, or the alarm does not power up, the batteries are depleted and must be removed.Do not leave depleted (¿dead¿) batteries in the alarm to avoid corrosion." at this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, spikes, trends and excursions above the control limits for this type of complaint will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Supplemental medwatch required for additional information.

• Brand Name: SITTER ELITE
• Type of Device: FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED
• Manufacturer (Section D): JT POSEY COMPANY; 5635 peck road; arcadia CA 91006 0020
• Manufacturer (Section G): POSEY COMPANY; 5635 peck road; arcadia CA 91006 0020
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6031868
• MDR Text Key: 57549979
• Report Number: 2020362-2016-00031
• Device Sequence Number: 1
• Product Code: PJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 8345
• Device Catalogue Number: 8345
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8309EL 30-DAY CHAIR SENSOR
• Patient Outcome(s): Death