MAUDE Adverse Event Report: SIZEWISE PULSATE 35; MATTRESS

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Fall (1848)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

Pt was found lying on left side next to bed.Pt states walking to bed and over estimated the height of the mattress which was inflated more in center.Pt states she slid to floor, denies pain, no injuries noted, no bleeding, pain, bruises.Pt was assisted to feet, dr.Contacted.Manufacturer response for pulsate mattress, pulsate 35 (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: 5131265
• MDR Text Key: 27692760
• Report Number: 5131265
• 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 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