MAUDE MDR 9903180

MDR report key
9903180
Report number
8043484-2020-00242
Event key
0
Event type
3
Date of event
2020-03-13
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DR SARAH FREESTONE
Address
101 HESSLE ROAD HULL HU3 2 UK
Phone
44-44-0447
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RENASYS GONEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPSMITH & NEPHEW MEDICAL LTD.OMPUNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING THERAPY THE PATIENT WAS HAVING PROBLEMS WITH THE MACHINE. HIS RENASYS GO WAS STARTED AFTER REMOVAL OF DEBRIS FROM INFECTED TOES. THE NURSE REPORTED THAT LAST NIGHT((B)(6) 2020) THE PATIENT TURNED OFF THE DEVICE AND THE NURSE RESTARTED THE DEVICE TODAY((B)(6) 2020). ALTHOUGH SCREEN REGISTERS AS CONTINUOUS 120 MMHG WITH GREEN LIGHT LIT, SHE REPORTED THAT THEY DON'T FEEL THE SUCTIONING MOTION OF THE DEVICE. SHE STATED THAT THE PATIENT HAS HAD DRESSING CHANGE YESTERDAY AND IT WAS STILL WORKING FINE. THE NURSE TRIED TURNING OFF THERAPY, POWER DOWN DEVICE AND PLUG INTO ELECTRIC OUTLET, THEN RESUMING THERAPY, BUT STILL NO SUCTIONING AND NO DRAINAGE (PREVIOUSLY PATIENT HAD SMALL AMOUNT OF DRAINAGE). THE NURSE CONFIRMED DRESSING APPEARS COMPRESSED. DISCUSSED PROBABLY CAUSES SUCH AS MISALIGNMENT OF SOFT PORT WHICH WOULD REQUIRED A DRESSING CHANGE. ALSO DISCUSSED TO ENSURE THAT THE OPENING IS LARGE ENOUGH AND CENTERED. NO BACKUP DEVICE WAS AVAILABLE AND NO INJURY TO THE PATIENT WAS REPORTED. IT IS UNKNOWN HOW THE TREATMENT PROCEEDED. NO FURTHER INFORMATION AVAILABLE.