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

Model Number 4AR794

Device Problem Component Misassembled (4004)

Patient Problem Fall (1848)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(4).Spoke with customer 2-27-19.They confirm the service visit was completed.The customer confirmed technician came out 2-25-19 and confirmed they installed caster cups.Customer requires no further assistance.

Event Description

Customer purchased bed on (b)(6) 2019.Bed was delivered on 02/18/2019.Customer called to advise the bed's wheels slipped around on her hardwood floor.Customer states she slipped attempting to get in the bed; she states that she was fearful of exiting base because the bed was not stable.Customer called 911 for assistance with exiting the bed.Customer confirms she was not injured.Customer states that she is (b)(6) and weighs (b)(6).Customer was advised to lock the wheels on the legs of the base but customer states she is unable to do so because she suffers from copd.Customer disclosed she uses a walker and an oxygen tank to get around her home.The customer states that she has pushed the bed against the wall to eliminate movement until the caster cups are installed by the technician.

• 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 (Section G): 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: 8425289
• MDR Text Key: 138947877
• Report Number: 3008872045-2019-00005
• 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: 03/15/2019

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: 4AR794
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/15/2019
• 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 Age: 65 YR
• Patient Weight: 159