MAUDE Adverse Event Report: LINET AMERICAN LINET BED EXIT ALARM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/08/2016

Event Type  Other  

Event Description

Pt determined to be at risk for falling.As a preventative measure, the liner integrated bed alarm was engaged so that staff would be alerted if the pt exited the bed.The staff apparently forgot to re-engage the alarm during the night.Staff were unaware that the pt exited the bed.The pt fell and broke his rib.The indicator light for the bed alarm is very small and staff need to go to the head of the bed to see if it is on.We would life for this light to be more visible.More importantly, we challenge the mfr to design safety mechanisms that address human failures.Namely, we would like to have a bed alarm that automatically re-engages when weight is re-established on the bed.

• Brand Name: LINET BED EXIT ALARM
• Type of Device: BED EXIT ALARM
• Manufacturer (Section D): LINET AMERICAN; charlotte NC 28269
• MDR Report Key: 5888365
• MDR Text Key: 52636487
• Report Number: MW5064187
• Device Sequence Number: 1
• Product Code: KMI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 81