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

Model Number DFLAL-3680-M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 10/10/2017

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the end user, per the end user, "they ordered a dermafloat 42x80 lal mattress, instead a dermafloat 36x80 mattress lal was brought and field service technician strapped it on the frame and patient fell off the bed".The patient did not sustain any injuries.Upon speaking to the facility, the patient has tremors/parkinsons and moves a lot in bed.Per the patient's needs, the bed involved is a 42" width.Complaint# (b)(4) and ra# (b)(4) were entered into our system to have the mattress and control unit returned to joerns for investigation.As of this writing, the mattress and control unit has not been returned.

• Brand Name: DERMAFLOAT LAL SYSTEM
• Type of Device: AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 6966812
• MDR Text Key: 90705780
• Report Number: 3009402404-2017-00052
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2017

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
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/20/2017
• 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 Age: 73 YR