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

Model Number 8309EL

Device Problem False Alarm (1013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The sensor pad was returned with an 8645 alarm unit.Wrinkles and creases observed throughout the pad.Testing of the unit and sensor pad confirmed the reported issue of sensor was not connected even though it was.When the sensor receptacle 1 of the unit was tested with the returned sensor pad, the unit played/toggled the audio cue between, sensor attached and sensor detached if the sensor cable was moved by hand due to bent sensor pins inside the receptacle 1.When the sensor pad was activated and the cable was moved, the audio cue played the selected tone sound as a fail-safe feature.The sensor pad is functional and will perform as intended when using the sensor receptacle 2 of the unit.After the bent sensor pins inside the sensor receptacle 1 were raised up back to their original heights, the sensor receptacle 1 of the unit functioned as intended.The possible root causes for this deficiency: the sensor receptacle 1 of the returned unit may have been inserted with a foreign object accidentally that it is not intended for the sensor receptacle such as the nurse call connector or something else causing the sensor pins to be bent or misaligned and not making a good contact to the sensor connector or rj-11 when inserted.The unit was in used with a previous sensor pad, but the cable was stretched or caught in between the wheelchair mechanism leaving the sensor receptacle 1 with bent sensor pins.This could also be caused by yanking out the sensor connector from the receptacle without pushing down the release tab.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.The ifu states, to reduce the risk of serious injury or death, 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.Do not use the alarm, sensor or magnet if it does not activate each time weight is removed from the sensor, the chair belt sensor is unfastened, or magnet is removed from face plate.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 reported complaint via email.Patient fall experienced, alarm stated the sensor was not connected even though it was.Request to return both alarm and sensor pad.

• 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 91761
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 13636099
• MDR Text Key: 296614594
• Report Number: 2020362-2022-00011
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8309EL
• Device Catalogue Number: 8309EL
• Device Lot Number: 1341T179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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