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

Model Number 4AR792

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Fall (1848)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Unique id# (b)(4).After speaking with the customer's partner, (b)(6), she confirmed that when she transferred the customer into bed she pushed the bed causing the bed to move away and the customer to fall.(b)(6) confirmed that the installation was done correctly and that prior to the incident all casters were in caster cups.(b)(6) states that the customer has been admitted to hospice because she is terminally ill, and requires additional assistance that cannot be offered at home, per delivery manager- (b)(4).Based on the information provided by the customer; the complaint is reportable per cfr 21 803.3.Mdr 2018-00010.

Event Description

Bed was purchased friday 05 july, 2019; bed was delivered 07/11/2019.Received a message from a sales representative; (b)(4).Sales representative states that (b)(6), customer's partner, states that while attempting to assist the customer into bed, the bed slid 5 feet away from the customer causing her to fall.(b)(6), mrs (b)(6)'s partner, confirmed the castor wheels were locked at time of incident and that after the bed slipped they advised the castor cups were scattered all over the floor.(b)(6) states that the customer weighs (b)(6) and uses a walker to get around.(b)(6) confirms that no medial attention was sought due to fall.Mrs.(b)(6) requires the assistance of others to get in and out of bed, chairs and cars.

• 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; ft. lauderdale FL 33312
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 5192 sw 27th ave; ft. lauderdale FL 33312
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; ft. lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8880424
• MDR Text Key: 154108632
• Report Number: 3008872045-2019-00010
• 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: Inspection
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AR792
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• 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
• Patient Weight: 86