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 2020-03-31 for RENASYS GO UNKNOWN manufactured by Smith & Nephew Medical Ltd..
[185914447]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00242 |
| MDR Report Key | 9903180 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-31 |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-31 |