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

Model Number DFLAL-4280-M

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

Patient Problem Fall (1848)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, on (b)(6) 2019, mattress was deflating as reported by the facility.The facility had placed a foam mattress under the dflal so that the patient would not be laying on the frame.Fst found that two cells had come disconnected, made the proper repairs and inflated the mattress.The lvn and grand daughter placed the patient back on the dflal mattress that was still on top of the foam mattress.The fst stated that he instructed the lvn and grand daughter that the foam mattress would need to be removed as this would be a hazard to the patient.On (b)(6) 2019, it was reported by the facility that the patient had a fall incident due to having both the foam and dflal mattress on the bed frame at the same time.Numerous requests to this facility have been made to receive additional information and details related to this alleged incident report with no response from the facility.Complaint#: (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 have not been returned.

• Brand Name: DERMAFLOAT LAL SYSTEM
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• MDR Report Key: 8693470
• MDR Text Key: 149801002
• Report Number: 3009402404-2019-00035
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/10/2019

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-4280-M
• Device Catalogue Number: DFLAL-4280-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/12/2019
• 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