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

Model Number 4AM663

Device Problem Device Handling Problem (3265)

Patient Problem Fall (1848)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer was advised to install rubber caster cups under the second base as well but she declined stating that she prefers to have the ability to move the bed for cleaning and changing the sheets.Customer did state that there is a slight height difference with beds due to caster cups but she is fine with that.No further assistance is needed regarding this issue.

Event Description

Bed was purchased (b)(6) 2013 and was delivered (b)(4) 2013.Contacted customer to confirm the bed bases were strapped together at the time of delivery, spoke to (b)(6) and she states that she did not wish to have them strapped together for cleaning purposes.In addition, she stated that in (b)(6) 2016 her husband backed into the bed while attempting to put on a stocking, causing the bed to slide away as well as causing her husband to slide down to the floor slowly.She states her husband was not injured and medical attention was not necessary.Previous to the incident the beds were on laminate floor without rubber caster cups.(caster cups are suggested to prevent movement of bed on smooth surfaces).Customer indicated that she purchased one set of rubber caster cups for her husbands bed from (b)(6) last summer.Customer confirms that she has installed the rubber caster cups on mr.(b)(6)'s bed base only.Customer has indicated that his bed no longer moves.(b)(6) states her husband is (b)(6).

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC.; 7411 fisher island drive; miami beach FL 33019 0700
• Manufacturer Contact: jessica vivar ; 7411 fisher island drive; miami beach, FL 33019-0700 ; 9548280893
• MDR Report Key: 6977178
• MDR Text Key: 90844519
• Report Number: 3008872045-2017-00027
• 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: Patient Family Member or Friend
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 08/28/2017

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: 4AM663
• Device Catalogue Number: CMMOD1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 84 YR
• Patient Weight: 113