MAUDE Adverse Event Report: CRAFTMATIC INDUSTRIES CRAFTMATIC MODEL 1 BASE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 4AW099

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

Unique id #(b)(6).The customer was shipped a 60x80 legacy base that was delivered on (b)(6) 2020.On (b)(6) 2020 the customer, (b)(6) confirmed that the new base was delivered.The customer is satisfied.The base will be returned to leggett and platt for an investigation under rma 10907.A follow up submission to the fda will be completed upon receipt of the investigation results.Craftmatic is presently in the process of obtaining a udi.

Event Description

Customer states on (b)(6) 2020, while in the bed reclined, that when she was lowering the head of the bed she smelled wire burning, and immediately ceased use of the base.She states that after a moment that she felt the mattress warm to the touch.The customer called the fire department, she states they used a heat gun that sensed the motor was hot.The customer confirmed the massage was on at the time.The customer disclosed the massage is used 3-4 times a day everyday and that the massage session are reactivated up to 4 times in a row.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach, fl
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach, fl
• Manufacturer Contact: jessica vivar ; 3580 gateway drive; pompano beach, fl ; 97201053
• MDR Report Key: 9837126
• MDR Text Key: 191830367
• Report Number: 3008872045-2020-00006
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4AW099
• Device Catalogue Number: CMMMOD1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1