MAUDE Adverse Event Report: HILL-ROM, INC. ACCUMAX; MATTRESS, FLOTATION THERAPY, NON-POWERED

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 10/19/2018

Event Type  malfunction  

Event Description

Accumax mattress was compromised and not appropriate for patients; switched out for clean bed.

• Brand Name: ACCUMAX
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 8063610
• MDR Text Key: 126911677
• Report Number: 8063610
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2018

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
• 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: 10/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12775 DA