MAUDE Adverse Event Report: HILL-ROM, INC. ADVANTA 2 BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1190A

Device Problems Material Disintegration (1177); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2017

Event Type  malfunction  

Event Description

This did not involve a patient or patient care.During preventative maintenance by the clinical engineering dept, technicians noticed a trend in a plastic bushing disintegrating.The hospital has 170 of these beds and since scrutinizing these, nine have been sequestered.Note: not all beds have been inspected- just a small sampling.One bed was repaired before this trend was noted.Technicians were not sure this would be a hazard for patients.The area where failure is occurring would be the knee/foot section of the bed.Due to the failure there is a significant amount of movement (side play) at the knee/foot section.Hill-rom representative came on site to look at the beds and since they do not have any alert/recall regarding these issues and the beds are no longer under warranty, it would be up to the hospital to repair.Technicians suggest reporting this possible/probable defect.Manufacturer response for advanta 2 hill-rom hospital bed, hill rom advanta 2 (per site reporter).Per the technician, hill rom stated there was no recall/alert regarding this issue and the beds are no longer under warranty.

Event Description

This did not involve a patient or patient care.During preventative maintenance by the clinical engineering dept, technicians noticed a trend in a plastic bushing disintegrating.The hospital has 170 of these beds and since scrutinizing these, nine have been sequestered.Note: not all beds have been inspected- just a small sampling.One bed was repaired before this trend was noted.Technicians were not sure this would be a hazard for patients.The area where failure is occurring would be the knee/foot section of the bed.Due to the failure there is a significant amount of movement (side play) at the knee/foot section.Hill-rom representative came on site to look at the beds and since they do not have any alert/recall regarding these issues and the beds are no longer under warranty, it would be up to the hospital to repair.Technicians suggest reporting this possible/probable defect.Manufacturer response for advanta 2 hill-rom hosptial bed, hill rom advanta 2 (per site reporter): per the technician, hill rom stated there was no recall/alert regarding this issue and the beds are no longer under warranty.

• Brand Name: ADVANTA 2 BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6581190
• MDR Text Key: 75684327
• Report Number: 6581190
• Device Sequence Number: 1
• Product Code: FNJ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1190A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2017
• 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: NO; NO OTHER THERAPIES