MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for BIS 186-1001-RFB manufactured by Covidien Mfg Plainfield.
[80678254]
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
[80678255]
Medtronic received a report about the device not generating an audible alarm. The unit had recorded multiple events of errors and alarms which had not audibly alerted the nurses when it was checked by the biomed. Customer indicated that there is no patient injury with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008361498-2017-05265 |
| MDR Report Key | 6726550 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-23 |
| 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 | COVIDIEN MFG PLAINFIELD |
| Manufacturer Street | 2824 AIRWEST BLVD |
| Manufacturer City | PLAINFIELD IN 46168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46168 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIS |
| Product Code | OLW |
| Date Received | 2017-07-19 |
| Returned To Mfg | 2017-06-19 |
| Model Number | 186-1001-RFB |
| Catalog Number | 186-1001-RFB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG PLAINFIELD |
| Manufacturer Address | 2824 AIRWEST BLVD PLAINFIELD IN 46168 US 46168 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-19 |