MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-26 for SEER EVENT MONITOR LEADS 1 CHANNEL PATIENT LEAD SET 2042863-003 manufactured by Ge Healthcare.
[5837109]
The department is down to three sets of leads and ge has no plans of stocking the ekg leads, nor does the secondary supplier company plan on having any of these types of leads for at least a month. Ge gave no warning to the relenquishment of sales towards the leads and just stated," no eta on replenishment. " this problem continues. The manufacturer did not provide notice to the hospital and we are unable to get additional leads. ======================manufacturer response for cardiac monitor leads, seer event monitor leads (per site reporter). ======================the sales rep for ge healthcare informed me that they did not have them and did not offer a third party besides carefusion who could provide them. Carefusion's sales rep stated that the leads would not be available for at least three weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4826533 |
| MDR Report Key | 4826533 |
| Date Received | 2015-05-26 |
| Date of Report | 2015-05-26 |
| Date of Event | 2015-04-01 |
| Report Date | 2015-05-26 |
| Date Reported to FDA | 2015-05-26 |
| Date Reported to Mfgr | 2015-06-09 |
| Date Added to Maude | 2015-06-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEER EVENT MONITOR LEADS |
| Generic Name | CARDIAC CABLE, LEAD |
| Product Code | MWJ |
| Date Received | 2015-05-26 |
| Model Number | 1 CHANNEL PATIENT LEAD SET |
| Catalog Number | 2042863-003 |
| Lot Number | * |
| ID Number | * |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 9900 W. INNOVATION DR., RP 213 WAUWATOSA WI 53226 US 53226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-26 |