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

Model Number 4AM663

Device Problem Misassembled (1398)

Patient Problem Fall (1848)

Event Date 08/01/2014

Event Type  malfunction  

Manufacturer Narrative

On may 18, 2017, technician installed bed link kit and connected the bed bases together.Technician confirmed with customer that bases are no longer separating.

Event Description

Bed purchased on (b)(6) 2014 and delivered on (b)(6) 2014.Customer states the bases were not strapped together at the time of delivery only assembled side by side.Customer states she fell twice due to the bases separating.The first fall happened 2-3 months after the bed was delivered and the second fall occurred a year later.The customer confirms that no serious injuries were ever sustained due to these alleged incidents and that no medical intervention was ever needed.

• 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 33019-0700 ; 9548280893
• MDR Report Key: 6750365
• MDR Text Key: 81377302
• Report Number: 3008872045-2017-00010
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• PMA/PMN Number: K022387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4AM663
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2017
• 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