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

Model Number 8307

Device Problems Device Alarm System (1012); Failure to Sense (1559)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Product is scheduled to be returned but have not been received in by manufacturing at the time of this report.Therefore, this report is 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 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).No product returned at this time.

Event Description

Customer reported the sensor is not always sending a signal to the alarm to sound.A patient fell and suffered a scrape on his back.Additional information from the customer stated the scrape was cleaned and covered with a band aid.No other treatment was administered.The date the incident occurred was not reported.

Event Description

Supplemental required for additional information.

Manufacturer Narrative

Analysis did not confirm the reported event of the device not sending the signal to the alarm to sound.Instead analysis of the unit found inactive areas on the sensor pad that would cause it to continuously send signal to the alarm to sound.This could have been caused by the way the unit was stored as physical inspection of the device indicated the sensor was stored in a rolled up position.The product instructions for use advises to store the sensor pad in a laid flat position.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 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.(b)(4).

• Brand Name: ALARM SENSOR, BED SENSOR PAD 6MTH
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia 91006
• MDR Report Key: 7495953
• MDR Text Key: 107648870
• Report Number: 2020362-2018-00029
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 8307
• Device Catalogue Number: 8307
• Device Lot Number: 7179T052
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/16/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention