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

Model Number 4AM663

Device Problem Separation Problem (4043)

Patient Problem Fall (1848)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Bed serial numbers are (b)(4).Sent customer a set of bed straps that were delivered on 10/1/2018.Please note: three attempts have been made to reach customer to confirm the receipt of the bed strap and installation of the bed strap with no response from the customer.This complaint ticket will be closed.If the customer calls for assistance a new ticket will be opened at that time.Service provider confirms the installation was completed 10/12/2018.

Event Description

Spoke to (b)(6), he states he fell out of bed and broke his bed straps.Customer states last night at about 2:30 am, he was laying in bed and rolled into the middle where both mattresses and bases meet, at which point he fell in between the the mattress and the bases, resulting in the bed bases separating due to the bed straps breaking.Customer states he activated his "life alert" for help getting up, the customer states he did not sustain any injuries but does state that he is a little sore from the fall.Customer confirms that there are caster cups installed.Customer weighs (b)(6).

• 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: 8203869
• MDR Text Key: 131699446
• Report Number: 3008872045-2018-00019
• 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: 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: 4AM663
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2018
• 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: 77