MAUDE Adverse Event Report: HILL-ROM BATESVILLE CLINITRON R-H PH BRACKET UNIT; BED, AIR FLUIDIZED

Model Number P0801A03

Device Problem Fail-Safe Design Failure (1222)

Patient Problems Concussion (2192); Brain Injury (2219)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician inspected the bed and found the patient helper was completely functional and assembled correctly.Per the hill-rom user manual: failure to correctly attach the patient helper assembly could cause it to fall.Injury or equipment damage could occur.Do not remove or install the patient helper arm assembly when a patient is in the bed.Patient injury or equipment damage could occur.The technician in-serviced the staff at the account on how to properly remove the triangle from the patient helper assembly prior to performing patient transfers.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating a patient and an aid transferring a patient into the clinitron bed was hit by the patient helper triangle that was resting on top of the patient helper assembly.The patient sustained no injuries from the incident.The aid was transferred to occupational health at the account for evaluation and was diagnosed with a cerebral concussion.No medical treatment was required.The aid was put on light duty at work for a week and is now fully recovered.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: CLINITRON R-H PH BRACKET UNIT
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 6286377
• MDR Text Key: 66063365
• Report Number: 1824206-2017-00035
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/09/2017

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: Other Caregivers
• Device Model Number: P0801A03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 01/30/2017
• 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