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

Catalog Number CMMOD1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Customer was shipped non-slip mattress pads to stabilize the mattress on the base.

Event Description

(b)(6) states she fell at night, after getting out of bed to go to the rest room.She said that the bed was stuck up at the head, and when she went to get out of bed in the middle of the night, the mattress slid back, and she fell, hitting her hip on the end of the nightstand.She did say that the bed was working when it was delivered, and when she went to raise the head, the bed just stopped working.She did not seek any medical attention.And did not provide the date the event occured.

• 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 Contact: jessica vivar ; 7411 fisher island drive; miami beach, FL 33019-0700 ; 9548280893
• MDR Report Key: 6750624
• MDR Text Key: 81626061
• Report Number: 3008872045-2017-00016
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/07/2017

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 Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/28/2017
• 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
• Patient Weight: 104