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

Model Number 4AT056

Device Problem Temperature Problem (3022)

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

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Unique complaint id (b)(4).On 8/2/2018, service was completed on customers base, the technician replaced the base cover, the foot massage motor.Customer confirmed service completion and functionality.Customer is satisfied.

Event Description

On (b)(6) 2018 service repair provider sent service visit details for a service visit that was completed on 8/2/2018.The service information indicated that the technician noticed the foot massage motor burned a hole on the base cover and that the mattress has a burn mark.The customer was unaware of these burn marks and hole.The customer confirms that no injuries were sustained and that no medical attention was needed.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC; 5192 sw 27th ave; fort lauderdale FL 33312
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC; 5192 sw 27th ave; fort lauderdale FL 33312
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 7893898
• MDR Text Key: 120865594
• Report Number: 3008872045-2018-00011
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/18/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4AT056
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/20/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention