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

Model Number DFAPL-3680-M

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

Patient Problem Fall (1848)

Event Date 06/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to the manufacturer by the end user, per the end user, facility staff walked in and patient was already on the floor.The patient stated he had slipped out of the mattress.Per ines, the patient believes it is because of the smooth surface of the mattress.The patient sustained small abrasion to left knee and patient also stated he hit his head.Per facility staff vitals are stable, physician has been made aware and patient is being monitored.(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 APL SYSTEM
• Type of Device: PATIENT 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,, 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 8789360
• MDR Text Key: 150992164
• Report Number: 3009402404-2019-00043
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFAPL-3680-M
• Device Catalogue Number: DFAPL-3680-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• 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
• Patient Weight: 62