MAUDE Adverse Event Report: CLINITRON CLINITRON; AIR FLUIDIZED BED

Device Problem Leak/Splash (1354)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/23/2014

Event Type  Injury  

Event Description

Air fluidized mattress leaking/blowing fine sand from mattress on to floor.Caregiver attempts to contain w/buckets and towels.Upon further examination of bed exposed copper wiring noted below bed at bendable area of frame (where hob would raise up from).Client required being removed from the bed due to possible shock condition, also need to turn bed off due to blowing condition of leakage.With air fluid property turned off bed becomes very firm.Client not able to withstand firmness of solid mode of bed due to medical condition (stage 3 & 4 wounds).Bed was meant to help alleviate pressure to these areas.(b)(4) called twice, voice messages left both times.Spouse received call back from (b)(4) stating, would come to the home on (b)(6) 2014, round noon.

• Brand Name: CLINITRON
• Type of Device: AIR FLUIDIZED BED
• Manufacturer (Section D): CLINITRON
• MDR Report Key: 3807228
• MDR Text Key: 4371849
• Report Number: MW5036068
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 82