MAUDE Adverse Event Report: SIZEWISE PULSATE 35; MATTRESS

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Physical Entrapment (2327)

Event Date 05/09/2015

Event Type  malfunction  

Event Description

Pt found with feet and knees on floor and torso hanging off bed; pt then slid to floor.Pt denies any pain at this time.Manufacturer response for pulsate mattress, pulsate 35 (per site reporter): rep was invited to the facility falls committee.He explained that pulsate mattresses are not intended to be used with patients who are ambulatory but should only be used with patients who are confined to bed.He stated there are other mattresses that are available for ambulatory patients.He did inservices with staff from nursing units and physical therapy to help them understand how to best determine the type of mattress to be used.He agreed that his staff would also ask questions about patient status when the organization calls to order a mattress so the right mattress is brought to the patient.

• Brand Name: PULSATE 35
• Type of Device: MATTRESS
• Manufacturer (Section D): SIZEWISE; 1600 genessee st., suite 950; kansas city MO 64102
• MDR Report Key: 5131264
• MDR Text Key: 27692993
• Report Number: 5131264
• Device Sequence Number: 1
• Product Code: FNM
• 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
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 68