MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; BED,BASIC, SEMI ELECTRIC

Catalog Number MDR107002E

Device Problem Failure to Power Up (1476)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 03/02/2024

Event Type  Injury  

Manufacturer Narrative

According to the customer, the bed will not "go up or down" and as a result he's fallen out of the bed "4 times" when attempting to get out of the bed.The customer reported after he experienced the falls he called the "ambulance" to take him to the hospital.The customer reported the hospital confirmed a "shoulder fracture and rib fracture" with an "xray".The customer reported he has been taking prescribed "norco" for pain, but the pain has not resolved.The customer reported the hospital gave him a "wrap" to stabilize the fractures, but there is no indication of further medical intervention at this time.The customer reported he has been using this bed since july 2023 and the "motor" stopped working at the "beginning of march".It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, the bed will not "go up or down" and as a result he's fallen out of the bed "4 times" when attempting to get out of the bed.

• Type of Device: BED,BASIC, SEMI ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19110854
• MDR Text Key: 340236452
• Report Number: 1417592-2024-00502
• Device Sequence Number: 1
• Product Code: LLI
• UDI-Device Identifier: 40080196320999
• UDI-Public: 40080196320999
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2024

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 Catalogue Number: MDR107002E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 92 KG