Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE STRYKER AIR I SYSTEM; PATIENT AIR MATTRESS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

JOERNS HEALTHCARE STRYKER AIR I SYSTEM; PATIENT AIR MATTRESS Back to Search Results
Model Number 999-3315
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 04/25/2018
Event Type  Injury  
Event Description
It was reported to the manufacturer by the end user, per the end user, "patient's wife complained to hospital staff that air mattress burned patient.Per patient's wife, patient had burns on their back." complaint (b)(4) were entered into our system to have the mattress and control unit returned to joerns for investigation.As of this writing, the mattress and control unit have not been returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STRYKER AIR I SYSTEM
Type of Device
PATIENT AIR MATTRESS
Manufacturer (Section D)
JOERNS HEALTHCARE
1032 north 4th street
baldwyn MS 38824
Manufacturer (Section G)
JOERNS HEALTHCARE
1032 north 4th street
baldwyn MS 38824
Manufacturer Contact
felicia banks
1032 north 4th street
baldwyn, MS 38824
MDR Report Key7570862
MDR Text Key110135685
Report Number3009402404-2018-00029
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 distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/05/2018
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
Device Model Number999-3315
Device Catalogue Number999-3315
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/09/2018
Initial Date FDA Received06/05/2018
Was Device Evaluated by Manufacturer? No
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;
-
-