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

Model Number DFLAL-3680-M

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Multiple Fractures (4519); Vertebral Fracture (4520)

Event Date 03/05/2021

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that patient was laying on mattress and wife inflated mattress so high that patient fell out of bed and had a cut on his forehead and right arm bleeding at elbow.Fell out of bed on left side but ended up on his right side.Patient is in emergency room and is saying the right side of head is hurting.C2 and c3 vertebrate in neck is broke waiting on neuro surgeon to come in.Also compression fracture of t7, t8, t9, t10 and t12 in the spine at chest level.Said has foam mattress on bed under the air mattress.Daughter found father laying on ground and called 911.Complaint # (b)(4) was entered into our system to have the mattress and control unit returned for investigation.

• 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 ; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 11644336
• MDR Text Key: 261314737
• Report Number: 3009402404-2021-00002
• 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
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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
• Date Manufacturer Received: 03/09/2021
• 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): Life Threatening
• Patient Age: 82 YR
• Patient Weight: 83