MAUDE Adverse Event Report: JOERNS HEALTHCARE PRIVATE LABEL MATTRESS AND CONTROL UNIT; PATIENT AIR MATTRESS

Model Number 9993315SYS

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/02/2018

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, "this patient was on a lal mattress that overheated on (b)(6) 2018.The mattress was extremely hot to touch.The pump was immediately turned off when discovered and uhs was called.The pump was switched out later that evening and the issue was resolved.The patient developed 3 darkened areas appearing to be burns that were not present the morning of the incident.One of the blisters has ruptured on (b)(6) 2018." 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 has not been returned.

• Brand Name: PRIVATE LABEL MATTRESS AND CONTROL UNIT
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; 1032 north 4th street; baldwyn MS 38824
• Manufacturer (Section G): JOERNS HEALTHCARE; 1032 north 4th street; baldwyn MS 38824
• Manufacturer Contact: felicia banks ; 1032 north 4th street; baldwyn, MS 38824
• MDR Report Key: 8104506
• MDR Text Key: 128386302
• Report Number: 3009402404-2018-00075
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9993315SYS
• Device Catalogue Number: 9993315SYS
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2018
• 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