MAUDE Adverse Event Report: HILL-ROM, INC ENVISION E700 WOUND SURFACE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number E700

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/31/2017

Event Type  malfunction  

Event Description

A customer with multiple skin issues was on an envision mattress that continued to malfunction.Hill rom was notified and a technician came to the customer's bedside and reported that there were no replacement envision mattresses available at the time.Staff have reported on numerous alarms that do not allow the envision mattresses to function properly and that hill rom technicians are unable to resolve any of the issues with mattresses not working properly.Unfortunately, the details of these events are very vague.Hill rom was notified and is reviewing issues and why the technicians were unable to resolve them.Hill rom's review and determination was reported back as follows: "there are times that the blower will display an error code.Sometimes there is not truly a repair on the mattress, but rather just arrest of the blower.The mattress will continue to provide the therapy required during this time, but attention is needed as to why the error code is appearing on the blower.".

• Brand Name: ENVISION E700 WOUND SURFACE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): HILL-ROM, INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6773258
• MDR Text Key: 82030061
• Report Number: 6773258
• Device Sequence Number: 1
• Product Code: IOQ
• 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
• Report Date: 07/14/2017,08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E700
• Device Catalogue Number: P741A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR