MAUDE Adverse Event Report: VOLKER VOLKER 5380 BED; AC POWERED ADJUSTABLE HOSPITAL BED

Model Number P53800000016

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

The bed has been returned to hill-rom for investigation.Upon initial evaluation visible marks under the bed's foot section were noted indicating that repetitive pressures were likely applied when lowering the bed, thus causing a gradual dislodging of the actuator until its complete withdrawal.This is turn caused the bed's foot section to fall when the caregivers tried to put the actuator back in place.At the user facility the bed was found to be up against the radiator.When the actuator fell, the bed ended up being supported by the radiator only, and when the nurses shook the bed to put the actuator back in place, it moved from the radiator and the fell onto the caregivers arms.The investigation is ongoing.If additional information is received a follow-up report will be filed.

Event Description

Hill-rom received a report from user facility stating, "the caregivers lowered the bed electrically and during descent the bed made a snapping noise then stopped lowering.Both caregivers saw that the actuator under the bed was partially detached, and trailing on the floor.The student nurse tried to put the actuator back in place, therefore placing both her lower arms under the bed.All of a sudden, the bed's foot section fell (the patient was still lying in bed), with the student's arms stuck between the lift arms.The student nurse sustained cuts to her right hand and a triple fracture of the left forearm requiring surgical repair.The patient was not injured.(b)(4).

• Brand Name: VOLKER 5380 BED
• Type of Device: AC POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): VOLKER; wullener feld 79; witten, westphalia, nordrhein-westfalen 58454 ; GM 58454
• Manufacturer (Section G): HILL-ROM INC.; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: jill burnett ; wullener feld 79; witten, westphalia, nordrhein-westfalen 58454 ; GM 58454
• MDR Report Key: 5729876
• MDR Text Key: 48421196
• Report Number: 3003086376-2016-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P53800000016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention