MAUDE Adverse Event Report: MOXI SASHORTMATT, SA MAX; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Device Alarm System (1012); Unintended Deflation (4061)

Patient Problem Fall (1848)

Event Date 12/12/2019

Event Type  Injury  

Event Description

Control unit was alarming and flashing lights.Mattress deflated and resident rolled out of bed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SASHORTMATT, SA MAX
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI
• MDR Report Key: 17537361
• MDR Text Key: 321148461
• Report Number: MW5144240
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR