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 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Unique id (b)(6).Customer was notified on (b)(6) 2019 that the base would be replaced.An investigation is pending upon receipt of the base.A follow up report will be sent to the fda when additional information is available.

Event Description

Spoke to (b)(6) customer claims the massage motor has come through the base cover and damaged the mattress.Customer states that the issue is on her side.The massage issue is at the head, not the foot.This happened after they had moved.Customer confirms the bed was intact and nothing was removed.The beds were moved by themselves.Customer states she uses the massage once daily and puts it on when goes to bed at night.She states she turns the massage back on once or twice at the end of the cycle when it turns off.Customer states that sometimes she has to wait because it will not turn back on right away.She states she hardly ever uses the foot massage.Customer has not been injured and has not needed medical attention.

• 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: 9213704
• MDR Text Key: 191831385
• Report Number: 3008872045-2019-00014
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Yes
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/21/2019
• 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): Required Intervention