MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-17 for KENDALL 33533T manufactured by Covidien Lp.
[72891865]
Patient Sequence No: 1, Text Type: N, H10
[72891866]
We use covidien/kendall's dl disposable cable and lead wire system (cat # 33135t & 33136t)with our ge monitors. Covidien/kendall provides an adapter that must be used between the ge monitor and the disposable lead wires. The connectors do not last long before failing. We have communicated our concern to our sales reps and have been told the probable issue is the user isn't lining up the pins correctly before inserting into the adapter or the monitor. Education has been provided by the former sales rep but the issues continue. Covidien/kendall provide us about 10 new adapters a month with no questions ask. They are always glad to send more. However, biomed recently raised a concern that when they are inspecting monitors for failure, the issue often is the adapter has failed not the monitor. Manufacturer response for dl disposable cable and lead wire adapter, kendall (per site reporter): the manufacturer states the failure is most likely because the user is not lining the pins up correctly before insertion or being careless when using plugging into the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6496909 |
| MDR Report Key | 6496909 |
| Date Received | 2017-04-17 |
| Date of Report | 2017-04-14 |
| Date of Event | 2017-04-14 |
| Report Date | 2017-04-14 |
| Date Reported to FDA | 2017-04-14 |
| Date Reported to Mfgr | 2017-04-14 |
| Date Added to Maude | 2017-04-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-04-17 |
| Model Number | 33533T |
| Catalog Number | 33533T |
| Lot Number | 237330 |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-17 |