MAUDE Adverse Event Report: KCI KCI ATMOS AIR; AIR MATTRESS

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Abrasion (1689); Tissue Damage (2104)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

Air mattress pump failed.Newly formed wound-skin denuded/abrasion found on d/c.New wound on right buttock.Mattress plugged in, but was not powered due to loose wire inside pump.

• Brand Name: KCI ATMOS AIR
• Type of Device: AIR MATTRESS
• Manufacturer (Section D): KCI; san antonio 78265
• MDR Report Key: 4368596
• MDR Text Key: 5292264
• Report Number: MW5039824
• Device Sequence Number: 1
• Product Code: INX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2014

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: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 76