MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ATMOSAIR 4000

Device Problems Inflation Problem (1310); Leak/Splash (1354); Defective Component (2292)

Patient Problem Pressure Sores (2326)

Event Date 04/10/2015

Event Type  Injury  

Event Description

Initially, arjohuntleigh has received a customer complaint with info that the mattress was found to be faulty.Inspection of the device at the customer side showed the sat valve was in place, cells were not twisted but there were leaks from the tubing found.On (b)(6) 2015 report from the (b)(6) which was matched to this complaint, has been received.Based on the report we confirm that: mattress had bottomed out at torso section; pt developed a pressure ulceration to the right ankle; it remained unclear if mattress fault had an impact on the pt outcome.On (b)(6) 2015 a telephone interview with the customer has been made in order to obtain all necessary info to fill up the incident description form (idf).During the interview following info was confirmed: (b)(6) female has been using the mattress while the issue occurred; ward staff checked mattress as it appeared to be bottoming out in the center area; staff noticed that the pt has stage 3 pressure damage (injury assessed as right lateral malleolus grade 3 (1 cm by 0.75 cm x 1 cm deep); the pt did not go to the emergency room and was treated with a cavillon spray and extra thin duoderm dressing.Mfr #3009988881-2015-00034.

• Brand Name: ATMOSAIR 4000
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 4848140
• MDR Text Key: 17308407
• Report Number: 1419652-2015-00185
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 66