MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. FLUIDAIR

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for fluidair family, we have not found any event with similar fault description compared to the one investigated here: the unintended bed movement during the repositioning the pt on the device.There is no trend observed for reportable complaints with this type of event for the fluidair devices.Based on the collected info it seems the most likely that the root cause of this failure is device malfunction - loose brake issue which together with a likely improper pt handling position lead to the hazardous situation.In this event, the brakes were not fully engaged as a brake bolt was loose.Therefore when the nurse tried to move the pt up in the bed, without using the recommended dri-flow system, and the bed moved.As a result the nurse aide who was trying to hold the bed and pull the pt up suffered back injury - or rather a muscle strain/soreness.In summary, the device failed to meet its specification while being used for a pt treatment.Caregiver suffered muscle strain/soreness, there were no injuries for the pt.Given the circumstances and the fact that this incident appears to be an isolated one, we shall continue to monitor for any further events of this nature and do not propose any further action of this time.

• Brand Name: FLUIDAIR
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78249
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd; suite 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 4958 stout drive; san antonio, TX 78219 ; 2103170412
• MDR Report Key: 4433049
• MDR Text Key: 15109773
• Report Number: 3009988881-2015-00006
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Remedial Action: Repair
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1