MAUDE Adverse Event Report: DRIVE; ADJUSTABLE BED

Model Number 15561

Device Problem Installation-Related Problem (2965)

Patient Problems Head Injury (1879); Laceration(s) (1946)

Event Date 11/16/2020

Event Type  Injury  

Event Description

Drive devilbiss healthcare was contacted regarding an incident involving a patient that fell off of a home healthcare bed.The patient's son reported that his mother rolled off of the bed onto the floor, hitting her head and sustaining a laceration, and was transported to the hospital.The patient's son reported that the incident occurred because neither he nor his mother's in-home healthcare providers were ever able to attach the left bed rail to the bedframe.The patient's son reported that the right bed rail was in use, and was unable to specify any defect in the left bed rail or reason that it was unable to be attached to the bed.In addition, the patient's son never contacted the bed's distributor regarding the incident, and only first contacted drive devilbiss healthcare regarding the incident approximately one year after it occurred, and had discarded the bed and rail.Therefore, drive was unable to retrieve or evaluate the product.At the time of the incident, the patient was transported to the hospital and was initially "lucid and recovering from the trauma resulting from [the] faulty bed rail," but was diagnosed with covid upon arrival at the hospital, and passed away from covid shortly afterwards, which her son stated was "not directly related to her fall.".

• Brand Name: DRIVE
• Type of Device: ADJUSTABLE BED
• MDR Report Key: 15046602
• MDR Text Key: 296137438
• Report Number: 2438477-2022-00066
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00822383963525
• UDI-Public: 00822383963525
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 15561
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2022
• Distributor Facility Aware Date: 11/03/2021
• Event Location: Home
• Date Report to Manufacturer: 07/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 96 YR
• Patient Sex: Female