MAUDE Adverse Event Report: HILL-ROM BATESVILLE PRIMA PREVENTION MATTRESS; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number P576CA1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Asphyxia (1851)

Event Date 09/20/2019

Event Type  Death  

Manufacturer Narrative

The prima prevention mattress is a basic foam mattress with no therapy functions.During hillrom's onsite visit to the account, it was discovered the bed frame and side rails were not hillrom products (the bed frame and side rails were invacare carroll devices).The hillrom service technician found the prima prevention mattress foam and covering to be intact.The mattress label was missing and therefore a serial number could not be identified.A customer purchase search was performed and noted the account's last purchase of the prima prevention mattress was in 1999.The prima prevention mattress production ceased in 2007 and has reached the end of its useful life as identified in the design requirement specifications.The prima prevention mattress functioned as designed while being utilized with a non-hillrom bed frame and side rails.The bed frame and side rail manufacturer would determine during product design testing which surfaces the bed frame and side rails are recommended for use.Invacare, the bed frame and side rail manufacturer, has been notified about this incident.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account stating the patient was found deceased during normal nursing rounds with her legs on the floor and her head between the mattress and siderail of the bed.The coroner told the account the death was caused from accidental positioning asphyxiation.The bed was located at the account at the time of the incident.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: PRIMA PREVENTION MATTRESS
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• 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: 9203654
• MDR Text Key: 162688348
• Report Number: 1824206-2019-00417
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2019

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: P576CA1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/17/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 94 YR
• Patient Weight: 91