MAUDE Adverse Event Report: HILL-ROM HILL ROM; INTENSIVE CARE UNIT PATIENT BED

Model Number 10000

Device Problems Sticking (1597); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 05/16/2018

Event Type  malfunction  

Event Description

Patient coded while bed was in high fowlers position.Stepped on the cpr button at the foot of the bed, but the head of the bed did not go down.Only 1 button on the bed worked and that is the internal left panel.Cpr was done while bed was in semi fowler due to inability to lay bed flat.Bed was serviced and the left siderail and valve were replaced.

• Brand Name: HILL ROM
• Type of Device: INTENSIVE CARE UNIT PATIENT BED
• Manufacturer (Section D): HILL-ROM; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 7586155
• MDR Text Key: 110600027
• Report Number: 7586155
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 10000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Outcome(s): Other