MAUDE Adverse Event Report: POSEY, S. DE R.L. DE C.V. POSEY SITTER ELITE BED ALARM PAD; MONITOR, BED PATIENT

Catalog Number 8283

Device Problem Defective Alarm (1014)

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

Event Date 09/23/2020

Event Type  malfunction  

Event Description

Bed alarm pad not working when tested.Not used on patient.Fda safety report id# (b)(4).

• Brand Name: POSEY SITTER ELITE BED ALARM PAD
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): POSEY, S. DE R.L. DE C.V.
• MDR Report Key: 10628040
• MDR Text Key: 210007491
• Report Number: MW5097053
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 100 YR