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

Model Number 4AR790

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(4).I advised the customer how to safely get in and out of the bed.I explained that the movement of the base was caused by forcefully entering and exiting the bed while on caster wheels that were in caster cups, i explained that because his daughter removed the caster wheels from the legs; having the legs in the caster cups should prevent any movement on their hardwood floors going forward.

Event Description

Customer states on (b)(6) 2019, he was getting out of bed to go to his walker and when he pushed off the bed, the motion forced the bed to back away from him which caused him to fall on the floor.The customer confirms the caster wheels were locked and the legs were in the rubber caster cups at that time.The customer states that the first time he fell, he was transferring from his wheelchair to get into bed, he plopped on the bed and the bed moved.He called the firehouse, for assistance to get off of the floor.He weighs about (b)(6) pounds.The customer does not have the assistance of a caregiver to get in and out of the bed, he lives alone.The customer states that he purchased a craftmatic bed because he had a hospital bed that he did not like.The customer states the bed is one hardwood floor.The customer states he did not sustain any injuries from the falls.The customer confirms that his daughter has removed the wheels from the bed yesterday and only has the base legs inside a caster cup presently.

• 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
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 3580 gateway dr; pompano beach, fl
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; ft. lauderdale, fl ; 82808933
• MDR Report Key: 9832961
• MDR Text Key: 188690723
• Report Number: 3008872045-2020-00003
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AR790
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• 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): Other
• Patient Weight: 134