MAUDE Adverse Event Report: RAYE'S, INC DBA SIZEWISE MANUFACTURING PULSATE BLOWER ASSEMBLY MATTRESS CONTROL UNIT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Patient Problem Insufficient Information (4580)

Event Date 09/19/2023

Event Type  Injury  

Event Description

An employee of (b)(6) or patient or patient family member in some way pulled the receptacle that is attached to the blower by two rivets.This receptacle was pulled out and pulled away from the three wires connected into the back of it.The individual who did this then draped the broken end of the cord over the head of the head of the bed and left it there.At some point later a nurse came as the mattress was not inflating because the cord and receptacles had been pulled out of the blower.When the nurse grabbed the cord because it was still plugged in to the wall it sparked and there was a pop.

• Brand Name: PULSATE BLOWER ASSEMBLY MATTRESS CONTROL UNIT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): RAYE'S, INC DBA SIZEWISE MANUFACTURING
• MDR Report Key: 17877451
• MDR Text Key: 325078337
• Report Number: MW5146612
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1