MAUDE Adverse Event Report: JOERNS HEALTHCARE DOLPHIN AUTOVECTOR SYSTEM; PATIENT AIR MATTRESS/CONTROL UNIT

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Ulceration (2116)

Event Date 11/26/2013

Event Type  No Answer Provided  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility staff selected chair mode to offset the pressure to the ischium which inadvertently displaced the pressure to the sacrum/buttock area.The bed did not fluidize that area for an extended amount of time resulting in inadequate tissue perfusion and worsening of wounds, requiring excisional débridement.(b)(4) contacted (b)(6) hospital to confirm event and model number of mattress/control unit.The facility said that they changed the settings and did not return to the pts room to change the settings back to fluidize the mattress.The facility was unable to provide model number for the mattress/control unit.The mattress/control unit were rented for the pt from recover care.Recover care was contacted multiple times to obtain the model number for the mattress/control unit and were not able to provide the info.(b)(4).

• Brand Name: DOLPHIN AUTOVECTOR SYSTEM
• Type of Device: PATIENT AIR MATTRESS/CONTROL UNIT
• Manufacturer (Section D): JOERNS HEALTHCARE; arlington TX
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 3653037
• MDR Text Key: 16782246
• Report Number: 3009402404-2014-00004
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: ASSET TAG# 102412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2014
• Distributor Facility Aware Date: 11/26/2013
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2014
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 75