MAUDE Adverse Event Report: J. T. POSEY CO. SITTER SELECT

Model Number 8361

Device Problem Defective Alarm (1014)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 09/16/2014

Event Type  Injury  

Event Description

The customer reported that when they removed the pt from the sensor, the hold button was selected and the pt was removed.When the pt was placed back on the sensor, the hospital personnel was not sure if they heard the alarm "beep" or not indicating the alarm was now in monitoring mode.The customer reported the patient then got up off the sensor and fell, breaking their hip.The pt had hip surgery on (b)(6) 2014 and is recovering in the hospital.The customer reported the alarm did not sound all.The customer's biomedical department personnel tested the alarm after the event and found that the alarm sounds when released from hold mode but there is a 20-25 second delay to indicate the alarm has transitioned from hold to monitor mode.

Manufacturer Narrative

Results: evaluation of the alarm and sensor received found when the alarm was tested with the sensor, the hold functions properly and there are no functional issues found with either device.The alarm is missing the moisture detection label and one battery spring is slightly deformed by functions.(b)(4).

• Brand Name: SITTER SELECT
• 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: 4193179
• MDR Text Key: 5150296
• Report Number: 2020362-2014-00338
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8361
• Device Catalogue Number: 8361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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: OVER-THE-MATTRESS SENSOR PAD: MODEL 8307,; LOT 4154T019
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 64