MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for THERMISTOR 400 MON-A-THERM CABLE 400 TM 5020410A manufactured by Sinbon Electronics-jiangyin.
[80637147]
The information provided indicates that the sample is expected to be returned for analysis. If the sample is returned, a summary of the analysis will be provided in a supplemental report. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[80637148]
(b)(6)2017 medtronic received notification of an interface cable was thought to be contaminated with pathogens in the icu. Follow up efforts are being made to collect further information related to the circumstances of this report. Updates will be provided in a follow-up report.
Patient Sequence No: 1, Text Type: D, B5
[107765242]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107765243]
On (b)(6) 2017 medtronic received notification of an interface cable was thought to be contaminated with pathogens in the icu. Follow up efforts are being made to collect further information related to the circumstances of this report. Updates will be provided in a follow-up report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2017-05334 |
| MDR Report Key | 6727128 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-07-04 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-07-04 |
| Date Added to Maude | 2017-07-19 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | SINBON ELECTRONICS-JIANGYIN |
| Manufacturer Street | NO. 288, MIDDLE CHENG JIANG RD JIANGYIN ECONOMIC DEVELOPMENT |
| Manufacturer City | JIANGSU,CN 214434 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 214434 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMISTOR 400 MON-A-THERM CABLE 400 TM |
| Generic Name | DEVICE, TEMPERATURE MEASUREMENT, DIRECT CONTACT, POWERED |
| Product Code | HCS |
| Date Received | 2017-07-19 |
| Model Number | 5020410A |
| Catalog Number | 5020410A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SINBON ELECTRONICS-JIANGYIN |
| Manufacturer Address | NO. 288, MIDDLE CHENG JIANG RD JIANGYIN ECONOMIC DEVELOPMENT JIANGSU,CN 214434 CN 214434 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-19 |