MAUDE Adverse Event Report: JENX LIMITED DREAMA SLEEP SYSTEM; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number DM36

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/26/2020

Event Type  malfunction  

Event Description

A soft support pad dm36 snapped off the bracket of a dreama sleep system whilst in use, there was no injury to the user.Fda safety report id# (b)(4).

• Brand Name: DREAMA SLEEP SYSTEM
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): JENX LIMITED
• MDR Report Key: 10546467
• MDR Text Key: 207606124
• Report Number: MW5096710
• Device Sequence Number: 1
• Product Code: IKY
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DM36
• Device Lot Number: 128665/128670
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 50