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

Model Number 4AW099

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The 5 inch adjustable legs that were installed the time of delivery are the standard leg included with all models, unless noted otherwise.There are no notes prior to delivery that indicate the bed height could be an issue.Advised caregiver that the shortest legs we have are 2 inches tall, she agreed, a technician will install the 2 inch legs, casters and caster cups.On (b)(6) 2018, spoke to (b)(6) (caregiver) can be reached at (b)(6), she states that the customer only needs the bed to be a couple of inches lower.Advised that the 3 inch legs will be different, but can be provided.3 inch legs were delivered on (b)(6) 2018, technician was requested (b)(6) 2018.Spoke to (b)(6) on (b)(6) 2018, the 3 inch legs have been installed, but the bed is too low for customer to get in and out of her wheelchair.Offered customer another set of legs, but not as a courtesy.Customer hung up the phone.On (b)(6) 2018 (b)(6), left a message for (b)(6), regarding new legs, the only other leg height option left is 4 inches, if customer still requires a technician, we can provide one for her.If customer agrees please advise replacement and technician is free of charge.

Event Description

Spoke with (b)(6) friend / caregiver, (b)(6) stated customers bed is too high.Spoke with caregiver on (b)(6) 2018, she stated that: customer has fallen trying to get in and out of the bed because the bed is too high.She also alleges that the there was one incident where the customer fell on the floor and had to call 911, she states the emt's did come help her off the floor and back into the bed.The caregiver states: the customer did not need to go to the hospital and confirms that the customer did not sustain any injuries.Customer is (b)(6) and weighs is (b)(6).Caregiver confirms the adjustable leg height is set at the top notch, 5 inches (which is the lowest height the leg can be adjusted to).

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC; 5192 sw 27th ave; fort lauderdale FL 33312
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8203860
• MDR Text Key: 131703431
• Report Number: 3008872045-2018-00018
• 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: Replace
• Type of Report: Initial
• Report Date: 12/20/2018

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: 4AW099
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/28/2018
• 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: 113