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U.S. Department of Health and Human Services

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

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JOERNS HEALTHCARE DOLPHIN AUTOVECTOR SYSTEM; PATIENT AIR MATTRESS/CONTROL UNIT Back to Search Results
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).
 
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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 Key3653037
MDR Text Key16782246
Report Number3009402404-2014-00004
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberASSET 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 FDA02/17/2014
Distributor Facility Aware Date11/26/2013
Event Location Hospital
Date Report to Manufacturer02/17/2014
Initial Date Manufacturer Received 01/31/2014
Initial Date FDA Received02/18/2014
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 Number1
Patient Outcome(s) Hospitalization;
Patient Age68 YR
Patient Weight75
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