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

Model Number 4AR790

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

Three attempts have been made to reach customer to schedule service visit with no response from the customer.Due to no response or further action required by the customer the complaint will be closed.If the customer calls for additional assistance with original complaint this complaint ticket will be reopened at that time.Should the customer contact us regarding this issue, a follow up submission for this mdr will be made at that time.

Event Description

(b)(6) said her bed leans to the right, on the edge of the bed.When asked how often she rotates the mattress, she said once a month.She said that even after it is rotated, it still leans to the right.She has rolled out of bed several times, and hit her forehead on the nightstand.She does not have the dates that she has rolled out, and does not know exactly how many times, she rolled out.She did not seek medical attention for any of these occurrences.Also asked her when she first noticed that her bed was leaning, and she said ever since her bed was delivered.She said she called several times, but there is no record of her calling.She weighs about (b)(6) lbs, and is 5 feet, 3 inches tall.

• 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 Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 7063387
• MDR Text Key: 93078467
• Report Number: 3008872045-2017-00040
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/05/2017

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: 4AR790
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 11/28/2017
• 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 Weight: 50