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

Model Number 4AM651

Device Problem Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

The device is currently in transit for the investigation, an update will be submitted to the fda upon receipt of the results.

Event Description

On (b)(6) 2016, the customer alleges the motor fell off the bed.On (b)(6) 2016 the customer contacted the service department, and stated "the motor fell off the bed, due to a weld break".On (b)(6) 2016 " the customer called and alleged "the motor of the bed collapsed, weld on the motor broke at the foot, in the middle of the night.The customer states her back popped, when the motor fell off the bed.She is in a lot of pain, and is going to see her doctor." customer is unsure of the date the bed collapsed and states she saw her doctor on (b)(6) 2016 and was prescribed a patch for her back pain.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC.; 7411 fisher island drive; miami beach FL 33019 0700
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 7411 fisher island drive; miami beach FL 33019 0700
• Manufacturer Contact: jessica vivar ; 7411 fisher island drive; miami beach, FL 33141 ; 9548280893
• MDR Report Key: 6139122
• MDR Text Key: 61591875
• Report Number: 3008872045-2016-00001
• 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: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/29/2016

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: 4AM651
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 12/01/2016
• 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