MAUDE Adverse Event Report: ARJOHUNTLEIGHT, INC. FLUIDAIR

Model Number 301000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, arjohuntleigh received a service call regarding the braking function of a bed.During the visit at the facility, the service consultant noticed that the brake bolt on the caster was loose and he tightened it backup and the nurse was satisfied.On (b)(6) 2014 around 1:00 pm representative of the customer called and explained that a nurse was injured while pulling a pt up i bed on the fluid air (injuries diagnosed as shoulder and back strain).The nurse aide did not receive any type of medical intervention and is now back at work on modified duties until the soreness subsides.Mfr ref #3009988881-2015-00006.

• Brand Name: FLUIDAIR
• Manufacturer (Section D): ARJOHUNTLEIGHT, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• MDR Report Key: 4433055
• MDR Text Key: 5420292
• Report Number: 1419652-2015-00028
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2014

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
• Device Model Number: 301000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other