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

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO; 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
 

SMITH & NEPHEW MEDICAL LTD. RENASYS GO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Catalog Number WD66021496
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2019
Event Type  malfunction  
Event Description
It was reported that the pump malfunctioned with the initial delivery.The pump ran like it has a seal for a minute.Then it would start running again and get hot to the touch.There were no delays, no back up and no patient harm reported.
 
Event Description
Pump malfunctioned with the initial delivery.The pump ran like it has a seal for a minute.Then it will start running again and gets hot to the touch.Besides, in the investigation during the functional evaluation, it was found the device failed the pressure test, confirming that the device could not generate or control negative pressure.The patient was not injured in any way.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RENASYS GO
Type of Device
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK 
MDR Report Key9616659
MDR Text Key175886710
Report Number8043484-2020-00053
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
PMA/PMN Number
C-0286746
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/22/2021
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 No Information
Device Catalogue NumberWD66021496
Initial Date Manufacturer Received 01/07/2020
Initial Date FDA Received01/22/2020
Supplement Dates Manufacturer Received01/22/2021
Supplement Dates FDA Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-