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

MAUDE Adverse Event Report: MEDELA AG INVIA MOTION+ 15 DAYS SINGLE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

  • 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
 

MEDELA AG INVIA MOTION+ 15 DAYS SINGLE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Model Number 0874012
Device Problems Failure to Run on Battery (1466); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2018
Event Type  malfunction  
Manufacturer Narrative
The device was requested for return.The customer did not want a replacement device.An evaluation of the device confirmed that this complaint is related to an issue in which otherwise fully functioning pumps display a battery missing error notification, which can be caused by repetitive unplugging and plugging when the battery is fully charged.This situation can potentially lead to a therapy interruption.The user is notified of such a malfunction via an audible and visual notification and is instructed via the instructions for use to contact their healthcare provider in order to receive a replacement device.
 
Event Description
On (b)(6) 2018, the customer alleged to medela llc that a patient had the pump squeezed between their leg and a chair and the pump felt warm and wasn't working on battery power.After approximately 45 minutes, the pump began working again on battery power.The customer indicated that there was no serious injury, the patient did not experience wound deterioration and the patient did not require consultation and/or treatment by a medical professional.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INVIA MOTION+ 15 DAYS SINGLE
Type of Device
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Manufacturer (Section D)
MEDELA AG
lattichstrasse 4b
baar switzerland 6341
Manufacturer (Section G)
MEDELA AG
lattichstrasse 4b
baar switzerland 6341
Manufacturer Contact
jan kloiber
1101 corporate drive
mchenry, IL 60050
MDR Report Key7422605
MDR Text Key105519197
Report Number1419937-2018-00104
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0874012
Device Catalogue Number0874012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2018
Distributor Facility Aware Date04/02/2018
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-