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

Model Number DFLAL-3680-M

Device Problems Inadequate or Insufficient Training (1643); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported to the manufacturer by the end user, per the end user patient fell out of bed and sustained a laceration to the right leg.The patient was sent to the hospital for treatment of the laceration and received stitches.Upon speaking to the facility, they mentioned that the bolsters on the mattress did not get inflated when the facility installed the mattress.A joerns associate visited the facility after the incident and provided training on bolster inflation.(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: 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, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• MDR Report Key: 7296053
• MDR Text Key: 100915622
• Report Number: 3009402404-2018-00010
• 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: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFLAL-3680-M
• Device Catalogue Number: DFLAL-3680-M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 02/26/2018
• 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