MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-27 for RENASYS GO 66021496 manufactured by Smith & Nephew Medical Ltd..
[185901688]
It was reported that the patient stated that his device has been displaying full blockage when there is no drainage in the canister at all. After the patient performed this first troubleshooting, the "canister full blockage alarm" did not get resolved. The patient stated that every time his device displays full blockage, he would still feel the suctioning motion and could feel that the device is still working. He confirmed that the tubing is never kinked or bent. After the patient performed this last troubleshooting step, the full blockage alarm got resolved. Informed the patient that since the alarm condition was resolved, the blockage was present within the soft port and per clinical guideline, this needs to be reassessed and replaced as needed. A back up device was not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00225 |
| MDR Report Key | 9892105 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENASYS GO |
| Generic Name | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
| Product Code | OMP |
| Date Received | 2020-03-27 |
| Catalog Number | 66021496 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |