MAUDE Adverse Event Report: SIZEWISE PULSATE 35; MATTRESS

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

Pt found down on the floor in room, pt states "i slipped off the bed when i sat down." manufacturer response for pulsate mattress, (brand not provided) (per site reporter): pulsate mattresses are not meant to be used with ambulatory patients.

• Brand Name: PULSATE 35
• Type of Device: MATTRESS
• Manufacturer (Section D): SIZEWISE; 1600 genessee st., suite 950; kansas city MO 64102
• MDR Report Key: 5131263
• MDR Text Key: 27693034
• Report Number: 5131263
• 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