MAUDE Adverse Event Report: AMERICAN NATIONAL MFG INC MATRIX ALAL AIR MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

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

Event Date 10/03/2023

Event Type  Injury  

Event Description

Cracked/broken connector on air mattress tubing caused air mattress to partially deflate.This caused the resident to fall from the bed and fracture a rib.

• Brand Name: MATRIX ALAL AIR MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): AMERICAN NATIONAL MFG INC; 252 mariah cir; corona CA 92879 1751
• MDR Report Key: 17924135
• MDR Text Key: 325745312
• Report Number: MW5146865
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/06/2023

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: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White