• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; DACAPO POWERPACK (TEMPO ACCU WYON)

  • 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
 

MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; DACAPO POWERPACK (TEMPO ACCU WYON) Back to Search Results
Device Problems Break (1069); Leak/Splash (1354); Chemical Spillage (2894)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Returned dacapo power pack showed a broken housing with electrolyte leakage.However, neither patient contact to battery chemistry nor any injuries were reported.
 
Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Type of Device
DACAPO POWERPACK (TEMPO ACCU WYON)
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
innsbruck
AU 
Manufacturer Contact
laura simonotti
fuerstenweg 77a
innsbruck A-602-0
AU   A-6020
6460705562
MDR Report Key4512089
MDR Text Key5406447
Report Number9710014-2015-00089
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/28/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/27/2015
Initial Date FDA Received02/09/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-