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

Model Number 4AT056

Device Problem Installation-Related Problem (2965)

Patient Problem Fall (1848)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

Unique complaint id (b)(4).Ordered customer a replacement base, that was delivered on 2/19/18.The replacement base works intermittently.A new ticket, ticket # (b)(4), was created for the replacement base issue.Ordered customer a replacement base.As of 5/18/2018 the customer no longer has the bed base.

Event Description

Spoke to (b)(6).The center of the bed is higher than the rest, he is the only person using the bed.On (b)(6) 2018, spoke with (b)(6); he stated that he has fallen out of the bed twice, he has not had any sleep, and he is still having the same problem with the bed.Spoke with mr (b)(6) on (b)(6) 2018; he states the bed is presently in the elevated position because the remote lowers and raises the bed extremely slowly; he states he needs to slide out of the bed base to get out of bed.He confirms he has mobility issues and is having more issues getting out of bed due to the uneven base.He states the base does not lay evenly when in the flat position.The customer confirms the base has not moved and that the mattress has not slid.Customer confirms that his fall was caused by his own mobility issues and not the bed.Customer confirms he has not suffered any injuries and no medical attention was sought.Customer would like the base replaced or a credit.

• 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: 7893893
• MDR Text Key: 120864933
• Report Number: 3008872045-2018-00010
• 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: 09/10/2018

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: 4AT056
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 09/20/2018
• 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