MAUDE Adverse Event Report: DRIVE DEVIL BLISS SIDHIL LIMITED FULL ELECTRIC BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 15216P

Patient Problem Fall (1848)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Describe the unusual occurrence: (b)(6) from bristol called to have the bed removed d/t patient fall.Per the daughter the patient was getting on the bed and used the wall slide on when bed suddenly moved and she fell between bed and wall.Per tile daughter she was never shown how to lock/unlock wheels on bed but when (b)(6) arrived to assess the fall he learn one of the wheels at the head failed to lock and appeared to be another issue at the foot (not fully described).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FULL ELECTRIC BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): DRIVE DEVIL BLISS SIDHIL LIMITED
• MDR Report Key: 17567324
• MDR Text Key: 321554077
• Report Number: MW5144697
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 15216P
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Sex: Female