MAUDE Adverse Event Report: POSEY PRODUCTS LLC ALARM SENSOR, CHAIR SENSOR PAD SQUARE 6MTH; MONITOR, BED PATIENT

Model Number 8308

Device Problems No Audible Alarm (1019); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product was not returned by the manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.Without the return of the device, the complaint cannot be confirmed.Based on previous complaint investigations, it can be speculated that either damage to the sensor pad or rj11 clip, folds and creases on the sensor, moisture, or wear and tear are the cause of the failure.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 provided adequate instructions and warning for the 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.Therefore, no corrective or preventive 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 emailed regarding a chair sensor pad that would not sound when the patient stood up.No indication of patient injury or incident.Customer stated the sensor is unable to be returned, may have been disposed of recently.The date the issue was discovered is unknown and no incident or serious injury was reported.

Manufacturer Narrative

H6: evaluation codes: the device was received in and inspected by the manufacturer.Visual inspection noted minor cosmetic damages.However, functional testing by the manufacturer was unable to confirm the reported issue with the sensor not sending a signal to engage the alarm.The unit was found to have met specifications and will send the signal to activate the alarm as designed.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 warrant.Manufacturer reference file #(b)(4).

Event Description

Supplemental required for additional information.

• Brand Name: ALARM SENSOR, CHAIR SENSOR PAD SQUARE 6MTH
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): POSEY PRODUCTS LLC; 2530 linsay privado drive; ontario CA 91761
• MDR Report Key: 10417685
• MDR Text Key: 203322840
• Report Number: 2020362-2020-00099
• 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
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8308
• Device Catalogue Number: 8308
• Device Lot Number: 9198T056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1