MAUDE Adverse Event Report: JOERNS HEALTHCARE DERMAFLOAT LAL; PATIENT AIR MATTRESS

Model Number DFLAL-3680-M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

This report or other informtion submitted by joerns healthcare under 21 cfr part 803, and and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

Event Description

It was reported to the manufacturer, by the end user, per the end user, that reported that the patient had slipped out of her bed.Her arm was entangled in the railing.They were afraid that her arm was broken so they called for an ambulance.She was picked up by eagle rock ambulance service and was transported to walnut creek kaiser emergency room.The patient currently has a sling on her arm but did not break any bones or have any serious injury.Son states his mother has advanced dementia and is in and out of sleep.A mattress has been placed on the floor next to the patient's bed because she has fallen out of the bed at least twice that son is aware of.She has been taken to er once before that he is aware of but he was not able to remember the last time.He said you can contact his sister with anymore questions because she was at the hospital when it happened.If you have any questions you can reach son.He is working with the patients doctor to get his mom a joerns bed.He has reached out to facility for rail assistance and they have not helped.He is very happy with joerns and hopes to get all of moms dme with us.Complaint #60133264 and ra #84091103 were entered into our system to have the mattress and control unit returned for investigation.As of this writing, they have not been returned.

• Brand Name: DERMAFLOAT LAL
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 16025311
• MDR Text Key: 305917530
• Report Number: 3009402404-2022-00038
• 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: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DFLAL-3680-M
• Device Catalogue Number: DFLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 45 KG