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

Model Number 8308

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but have not been received in by manufacturing at the time of this report.Therefore, this event is reported based solely on the information provided by the customer.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 warning for the safe and effective use of the device.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).Pending product return.

Event Description

Customer reported the sensor is not sending a signal to activate the alarm.The date the issue was discovered is unknown and no patient incident or injury was reported.No additional information was provided at the time of this report.

Manufacturer Narrative

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).

• Brand Name: ALARM SENSOR, CHAIR SENSOR PAD SQUARE 6MTH
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• MDR Report Key: 8095332
• MDR Text Key: 128067954
• Report Number: 2020362-2018-00152
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1