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

Model Number 4AW097

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

Bed serial numbers are (b)(4).Sent customer a set of bed straps that were delivered on (b)(6) 2019.On (b)(6) 2019 pilot's technician installed bed straps on customer's base.On (b)(6) 2019 customer, (b)(6) confirmed that bed straps have been installed that her bases are stationary.Based on the signed proof of delivery, a floor protector was in place at the time of the delivery, customer refused the install of the bed straps.Please note, a disclaimer is noted on all pod advising the importance of the installation of the bed straps.The customer is satisfied and requires no further assistance.

Event Description

Spoke with customer she stated that she is missing bed straps.Customer stated that due to the fact that the beds were not strapped the husband fell out of the bed customer stated the husband did not get but his head missed the end of the nightstand.

• 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: 8355481
• MDR Text Key: 136725654
• Report Number: 3008872045-2019-00003
• 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: 02/20/2019

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: 4AW097
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 02/20/2019
• 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