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

Model Number 4AR794

Device Problem Misassembled During Installation (4049)

Patient Problem Fall (1848)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(4).Service visit was completed but confirmation is pending, a follow up submission will be sent upon confirmation.

Event Description

On (b)(6) 2019 the customer, (b)(6) stated that the technician who serviced her bed on 9/25/19 that involved a height adjustment of the legs; did not lock the wheels.The bed moved causing the customer to fall to the floor.She was unable to get up and had to call 911.Customer was unable to provide additional details at the time of the call on (b)(6) 2019.

• 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: 9272295
• MDR Text Key: 166015259
• Report Number: 3008872045-2019-00017
• 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: Repair
• Type of Report: Initial
• Report Date: 10/22/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AR794
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 11/04/2019
• 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): Hospitalization