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

Model Number 4AR792

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Unique id# (b)(6).The customer states that since her fall she has pushed the bed against the wall to prevent movement.I advised the customer to look for the caster cups in the accessory box, she will check it.The customer was not aware that the caster wheels locked, she is not able to lock the caster wheels, she states the nob on the caster wheels does not go down.The customer does have mobility issues although at times she needs assistance getting around and getting in and out of the bed.The customer did ask someone at the home to lock the caster wheels and the home worker was unable to get the wheels to lock.Due to the covid 19 pandemic, the request for a service visit has been postponed until further notice.On (b)(6) 2020, i spoke to (b)(6) and advised the customer that a service provider could be provided if she still required assistance.The customer states that she will arrange for the caste wheels to be taken off her bed.Craftmatic is presently in the process of obtaining a udi.

Event Description

Spoke to (b)(6) on (b)(6) 2020, the customer states she was leaning against the bed while the foot of the bed was elevated.The customer then states the bed moved back causing the customer to fall on her buttocks and hit her head.The customer states the bed is on the carpeted floor and is on caster wheels with no caster cups in place under the wheels.The customer states she did not call 911, did not seek medical assistance and confirms that no injuries were sustained.The customer states she weighs (b)(6) pounds and is 5 foot 3 inches tall.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach, fl
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach, fl
• Manufacturer Contact: jessica vivar ; 3580 gateway drive; pompano beach, fl ; 82808933
• MDR Report Key: 9983466
• MDR Text Key: 191824645
• Report Number: 3008872045-2020-00007
• 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: Notification
• Type of Report: Initial
• Report Date: 04/21/2020

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: 4AR792
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/21/2020
• 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: 74