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

Model Number DFLAL-CU

Device Problem Device Fell (4014)

Patient Problem Injury (2348)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, during the night shift, a facility maintenance staff member was transporting a frame along with a dflal system from one room to another.The staff member failed to properly secure the control unit by placing it on top of the mattress.Instead the control unit was left hanging on the foot board that was attached to the facility owned frame.As the frame was being maneuvered in to position in the new room, it is unclear how the staff member managed to push the control unit off the foot board causing it to fall and land on the staff member's foot.(b)(6) made it clear to me that there was no failure with our product.Complaint# (b)(4) and ra# (b)(4) were entered into our system to have the control unit returned to joerns for investigation.As of this writing, the control unit has not been returned.

• Brand Name: DERMAFLOAT LAL CONTROL UNIT
• Type of Device: PATIENT AIR MATTRESS SYSTEM
• 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: 9372315
• MDR Text Key: 167974814
• Report Number: 3009402404-2019-00080
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFLAL-CU
• Device Catalogue Number: DFLAL-CU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2019
• 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): Hospitalization