MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for GRASS ELECTRODES F-E5GH-30 manufactured by Natus Manufacturing Limited.
[60847109]
Dhr for (b)(4) was obtained and reviewed. All manufacturing work steps have been completed and signed for as per route card. In process test form for grass electrodes was reviewed. All tests were completed and signed off. No failures recorded. Customer has been contacted to provide the rest of the required information. We are in the process of gathering additional information. A letter listing outstanding information has been sent to customer to obtain additional information in order to submit follow up report and/or explain why required information was not provided and steps taken to obtain such information. Device available for evaluation? - awaiting customer response if the device will be returned.
Patient Sequence No: 1, Text Type: N, H10
[60847110]
The first night of use, three patients have had major skin rashes and redness.
Patient Sequence No: 1, Text Type: D, B5
[73574323]
Four (4) grass electrodes were returned for investigation. No visual defects noted on inspection. No issues with the production of this lot of electrodes. The devices were found to have met specifications prior to shipment. No manufacturing anomalies were identified that may have caused or contributed to the reported event. This is the first event reported for this lot number to date. Based upon the available information a definitive root cause cannot be determined. It is unknown whether patient factors or cleaning process may have contributed to the reported event. Customer has been contacted on numerous occasions to provide the required information. The feedback received in relation to the below information was marked as not applicable. Patient identifier, age at the time of event, date of birth, weight, relevant tests/laboratory data, including dates, other relevant history, including preexisting medical conditions (e. G. , allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc. ), concomitant medical products and therapy dates (excludes treatment of event). Correction information in the operator of the device has been specified more from health professional to nurse based on the customer feedback. Information in the initial reporter and occupation has been corrected to health professional and other health professional respectively based on the initial reporter. Information in initial reporter corrected from the initial report 3005581270-2016-00006 to the below: (b)(6). Despite our best efforts contact details for the contact person for initial reporter (healthcare facility) could not be obtained from the distributor that originally reported adverse event that happened in the healthcare facility. Distributor advised they can be contacted in the case of additional information required. Below is the distributor details: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2016-00007 |
| MDR Report Key | 6126496 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-10-14 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2016-11-23 |
| 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 | MR. MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 35391 6474 |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | GORT, CO. GALWAY H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRASS ELECTRODES |
| Generic Name | GRASS GENUINE CUP ELECTRODES |
| Product Code | GXY |
| Date Received | 2016-11-23 |
| Returned To Mfg | 2017-01-09 |
| Model Number | F-E5GH-30 |
| Catalog Number | F-E5GH-30 |
| Lot Number | 10218683 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK GORT, CO. GALWAY H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-23 |