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

Model Number 8309EL

Device Problem Communication or Transmission Problem (2896)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on the information provided by the customer.Confirmation of customer's complaint and the root cause could not be determined.Based on previous complaint investigations of no sound or product not sounding when it should, can be speculated that a damaged rj11 clip or folds and creases on the sensor, may have contributed to the reported issues.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.The ifu states "always check sensor pads when connecting them to a posey alarm.You can check a sensor pad by attaching it to the sensor input on the alarm, activating the alarm and placing pressure on the sensor pad.When the pressure is released, the alarm should sound.Repeat this pressure/release test in several different areas along the entire length of the sensor pad to ensure entire sensor pad functions properly.If the alarm and/or sensor pad do not function properly, remove the alarm and sensor pad from service and replace them with a properly functioning alarm and/or sensor pad.Do not use the alarm or sensor pad if it does not activate each time weight is removed from the sensor pad." 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, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file# (b)(4).Product will not be returning.

Event Description

Customer states that they sat the patient in the chair with the alarm activated.The patient got up when the staff was not there and it tripped the green light on the alarm but did not activate a tone.Customer states that the patient had a fall after they had gotten up and no tone sounded.Customer is uncertain if the fall resulted in an injury.Customer states they tested the sensors with multiple alarms.On each of the alarms, they were slow in arming response time.When pressure came off the pad the green light lit up and there was a delay in some cases for the alarm to sound.(b)(6) is going to go out there on monday (b)(6) 2020.She is going to find out more details if this was an injury and take a look at the sensors.No qtin information was available.Limited ability to further troubleshoot troubleshooting template has been created and saved to the drive.

• Brand Name: ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): POSEY PRODUCTS LLC; 2530 lindsay privado drive; ontario 91706
• Manufacturer Contact: chris rahn ; 570 enterprise drive; 5635 peck road; neenah, CA 54956 ; 9207514009
• MDR Report Key: 9803161
• MDR Text Key: 200844362
• Report Number: 2020362-2020-00020
• 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: Other
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8309EL
• Device Catalogue Number: 8309EL
• Device Lot Number: 9325T188
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• 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