MAUDE Adverse Event Report: HILL-ROM BATESVILLE NP50 80X35.5X6 MRS - FLAT; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number P50A7F

Device Problem Material Integrity Problem (2978)

Patient Problem Bacterial Infection (1735)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

User facility reported a serious fluid in the mattress.The facility did not do any testing to determine the nature of the fluid.The user facility reports that the patient developed (b)(6) and pseudomonas, they state they are monitoring and evaluating daily.Hill-rom received a portion of a representative sample np50 mattress topper for analysis, evaluation is pending.This is not from the mattress that is subject of this complaint.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hill-rom received a report from the account stating a patient acquired an infection.The mattress was located at the account.This report was filed in our complaint handling system as (b)(4).

• Brand Name: NP50 80X35.5X6 MRS - FLAT
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 6473059
• MDR Text Key: 72142117
• Report Number: 1824206-2017-00163
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: P50A7F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR