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

Model Number 4AR791

Device Problems Device Slipped (1584); Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Unique id: (b)(4).The customer was advised that the caster wheels are not designed to take repeated force, and that the best solution would be to remove the casters wheels from the base.The customer service representative offered a technician service visit, as well as explained how to remove the caster wheels.The customer understands and states he is unable to physically remove the caster wheels but will call at a later time if he wishes to have a technician remove the caster wheels.Craftmatic industries is presently in the process of obtaining a udi.

Event Description

Spoke to (b)(6) on (b)(6) 2020 at 11 am.The customer states that a couple days ago, while attempting to sit on the bed, the bed moved causing him to fall on the floor.The customer states he called emergency medical services to assist picking him up off the floor.The customer disclosed during the phone call, that he must use the bed for leverage whenever he enters or exits the bed.The customer has casters wheels on the base legs that can be locked and unlocked.The customer states the bed is on hardwood floor and an area rug under the bed.The customer confirmed that the area rug does not move.He is (b)(6) and 5 foot 9.Has mobility problems, walks with walker, uses wheelchair during outings.Does not require assistance getting in and out of bed.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach, fl
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach, fl
• Manufacturer Contact: jessica vivar ; 3580 gateway drive; pompano beach, fl ; 82808933
• MDR Report Key: 10650514
• MDR Text Key: 212803033
• Report Number: 3008872045-2020-00009
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4AR791
• Device Catalogue Number: CMMOD1
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/08/2020
• 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: 170