MAUDE Adverse Event Report: VOLKER VOLKER S960-2 BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number PS960-20000001

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problems Death (1802); Fall (1848); Head Injury (1879); Hemorrhage, Subdural (1894)

Event Date 06/04/2015

Event Type  Death  

Manufacturer Narrative

Hill-rom attempted to inspect the bed.However, the account could not locate which bed was involved in the incident.Per the service manual: all moving parts of the lifting gear, compact drive and assist rails are permanently lubricated during manufacture.The manufacturer assumes, however, that healthcare beds will be regularly inspected once a year and any damage such as loose screws or breakages will be dealt with at once.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The account repaired the bed and placed it back into service.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient was turned on their side for personal care.The siderail bent and came loose from the bed.The patient fell off the bed on top of the siderail hitting his head.The patient was transferred to the hospital.There was a minimal subdural visible on ct scan which continued to increase in size.Patient received surgical intervention for the cerebral hemorrhage.The patient died two days post injury.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: VOLKER S960-2 BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): VOLKER; wullener feld 79; witten, westphalia, nordrhein-westfalen 58454 ; GM 58454
• Manufacturer (Section G): VOLKER; wullener feld 79; witten, westphalia, nordrhein-westfalen 58454 ; GM 58454
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006
• MDR Report Key: 5070857
• MDR Text Key: 25550017
• Report Number: 3003086376-2015-00002
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PS960-20000001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 120