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

Model Number R4AT056

Device Problems Material Puncture/Hole (1504); Temperature Problem (3022)

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

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Unique id (b)(6).The base will be replaced for customer, the base is presently is transit to the customer.Confirmation of delivery is not yet available.Investigation is still pending, a follow up submission will be sent upon the receipt of the investigation results.

Event Description

Customer called on (b)(6) 2019 and states that she is having issues with her craftmatic base.Customer claims the massage motors are coming through the base of the bed.Customer claims it is the head and the foot massage motor that are coming through.The customer stated the massage unit is used every day, and when it turns off itself she turns it back on about three or four times every day.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC.; 3580 gateway dr; pompano beach FL 33069
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 3580 gateway dr; pompano beach FL 33069
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; ft. lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 9272116
• MDR Text Key: 191831120
• Report Number: 3008872045-2019-00016
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R4AT056
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other