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

Evaluation results: evaluation of the unit found that the sensor triggered the unit to sound when weight was removed from the pad as intended.When weight was applied on the sensor pad, the sensor did not trigger the unit to sound as intended.The returned sensor pad was tested with in-house 8345 unit.The sensor pad passed both the visual and functional testings and we were unable to replicate the customer's complaint of the product not sending the proper signal to the alarm.At this 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 warning 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, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file# (b)(4).

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.Heather is going to go out there on monday 02-17-2020.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 CA 91706
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 9806785
• MDR Text Key: 200844649
• Report Number: 2020362-2020-00019
• 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: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8309EL
• Device Catalogue Number: 8309EL
• Device Lot Number: 9305T057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• 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