MAUDE Adverse Event Report: POSEY PRODUCTS ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY; MONITOR, BED PATIENT

Model Number 8309

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Injury (2348)

Event Date 11/20/2016

Event Type  Injury  

Manufacturer Narrative

This event was discovered via maude report 5068636 and is based solely on the reported issue.The report did not provide the initial reporter information, therefore attempts to get additional event information or to get product back were not performed.The device instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states ¿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.Do not use the alarm or sensor if it does not activate each time weight is removed from the sensor, or if the chair belt sensor is unfastened.¿ (b)(4).Device not available for evaluation.

Event Description

Customer reported the patient was found on the floor in front of the chair.The alarm was on when the patient was assisted to the chair.The alarm and sensor did not seem to be working correctly when they were checked post-fall.Cushion was on top of the pad and alarm only went off some of the time when it was checked.There was a serious injury reported that required intervention, but the type of injury is unknown.

• Brand Name: ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): POSEY PRODUCTS; 5635 peck roas; arcadia CA 91006
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 16901. bo; colonia rio tijuana, 3ra. etap; tijuana, mexico 22664 ; MX 22664
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6553107
• MDR Text Key: 74700928
• Report Number: 2020362-2017-00015
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 8309
• Device Catalogue Number: 8309
• Device Lot Number: 6267T010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2016
• 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
• Patient Outcome(s): Other