MAUDE Adverse Event Report: HILL-ROM HILL ROM, INC.; TOTAL CARE BARIATRIC

Model Number 1900-00

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Reset (1532); Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

Patient Problem Respiratory Distress (2045)

Event Date 12/27/2015

Event Type  Injury  

Event Description

Patient was being reposition in hill-rom bariatric bed.Because of patient's morbid obesity, bed was placed in trendelenburg position to facilitate positioning patient up in bed.Once lift was complete, staff attempted to return the bed to level, hob increased.Bed would not respond to pressing on the reverse trendelenburg position.Staff noted the bed had locked all three (elevation, head and knee gatch) settings on bedrail.Attempts to unlock the bed as trained unsuccessful.Hill-rom tech and hospital biomedical engineering tech consulted.Instructions given were ineffective.Pillows and blankets placed under head to raise hob to facilitate breathing.After the position change, bed unlocked.Bedrail plastic covering of buttons found with breach of integrity - this was the control center used to change the bed's positioning.Hill-rom notified and examined device on site on (b)(6) 2015.Outcome of inspection: on monday (b)(6) 2015 (b)(6), a field service technician from hill rom was called to inspect the total care bariatric bed that was involved in the incident on (b)(6) 2015.I informed (b)(6) of the sequence of events that occurred, and what the nurses stated happened to the bed.We inspected the patient right side foot side rail, since that was the side the nurses were trying to operate the bed from.During the inspection we found that the bed control overlay, or label, on the outside of the side rail had a series of cuts in it.We then inspected the inside of the side rail to see if there was any evidence of a foreign substance on the electrical components.We were unable to see if there was any evidence of a foreign substance on the electrical components.We were unable to see any evidence of any substance.(b)(6) was also able to pull the list of error commands that were stored in the bed.The error that was recorded on (b)(6) 2015 was due to a scale issue (error code 50-1-33-0-0-0).After running the bed through all the normal operating functions, we found that the bed would not go into "chair position".This prevents the feet from lowering.The bed is currently sequestered and out of service until further notice.(b)(6) biomedical electronic technician (b)(6).

• Brand Name: HILL ROM, INC.
• Type of Device: TOTAL CARE BARIATRIC
• Manufacturer (Section D): HILL-ROM; batesville IN
• MDR Report Key: 5369243
• MDR Text Key: 36228828
• Report Number: 5369243
• Device Sequence Number: 1
• Product Code: IOQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2015

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: No Information
• Device Model Number: 1900-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2015
• Distributor Facility Aware Date: 12/27/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR
• Patient Weight: 190