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

Model Number 4AM665

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Fall (1848)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 12/14/2017 customer sent pictures, pictures confirm both cinch nuts located at the foot of the base have collapsed into the metal frame where the legs are screwed into.On 12/27/2017, cinch nuts were shipped to customer.Spoke to (b)(6) on (b)(6) 2018, he confirmed receiving the cinch nuts.Customer will have a local handy man install the cinch nuts and reinstall the legs.The customer has confirmed the legs on base did not break when the bed collapsed.No further assistance is needed.

Event Description

Spoke to (b)(6), on (b)(6) 2017.He states he fell (b)(6) 2017, he states he was sitting at the foot of the bed when the foot of the bed collapsed and the legs broke.Customer confirms the bed was in a flat position when he fell.Customer confirms that he was not injured and medical attention was not needed.Customer states that his nurse was present when he fell.Customer states the wood in the base is broken.Customer (b)(6).

• 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: 7201202
• MDR Text Key: 97985965
• Report Number: 3008872045-2018-00004
• 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: Other
• Type of Report: Initial
• Report Date: 12/13/2017

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: 4AM665
• 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: 12/13/2017
• Initial Date FDA Received: 01/17/2018
• 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
• Patient Weight: 145