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

Model Number 4AR790

Device Problem Device Issue (2379)

Patient Problem Fall (1848)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

The complainant was called on 12/16/2016 by a craftmatic adjustable beds representative, the complainant disclosed that her partner did not sustain any injuries and did not require any medical intervention.Complainant was contacted 12/19/2016 to schedule a pickup date for the base and mattress.The complainant at that time requested to keep the bed and requested to keep the bed and have a service technician scheduled to complete the installation.On 12/23/2016 complainant was contacted and customer decided to return the bed after all.A request to schedule the pick up of the mattress and base has been submitted but the date is pending.

Event Description

Complainant emailed craftmatic 12/16/2016, she alleges the bed when installed on (b)(6) 2016, the beds were not strapped together.The complainant states that the 2 twin beds separated and caused her partner to fall on the floor.The customer disclosed her partner did not sustain any injuries and did not require any medical intervention.

• 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 33141 ; 9548280893
• MDR Report Key: 6208882
• MDR Text Key: 63488637
• Report Number: 3008872045-2016-00003
• 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: Patient
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/16/2016

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: 4AR790
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 12/28/2016
• 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