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: GETINGE SUZHOU CO. LTD. ALPHA TRACELL DELUXE
  • 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
 

GETINGE SUZHOU CO. LTD. ALPHA TRACELL DELUXE Back to Search Results
Model Number ALT01
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2014
Event Type  malfunction  
Event Description
On (b)(6) 2014, the following was reported to (b)(4): the alpha trancell deluxe pump and mattress system was in use when smoke started emitting from the pump housing.The unit was switched off and removed from service.The patient was sitting in the chair at the time and although no injuries were sustained.The patient was moved to a different room until the smell subsided.
 
Manufacturer Narrative
(b)(4).Additional information will be provided upon conclusion of the investigation including actual device evaluation.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALPHA TRACELL DELUXE
Manufacturer (Section D)
GETINGE SUZHOU CO. LTD.
no. 158 fangzhou road
sip, suzhou, jiangsu,
suzhou 2150 24
CH  215024
Manufacturer (Section G)
GETINGE SUZHOU CO. LTD.
no. 158 fangzhou road
sip, suzhou, jiangsu,
suzhou 2150 24
CH   215024
Manufacturer Contact
pamela wright
12625 wetmore
ste 308
san antonio, TX 78247
2102787040
MDR Report Key4309272
MDR Text Key5212283
Report Number3005619970-2014-00010
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 11/26/2014,11/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberALT01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/26/2014
Distributor Facility Aware Date11/11/2014
Event Location Nursing Home
Date Report to Manufacturer11/26/2014
Date Manufacturer Received11/11/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-