MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-19 for MICROSTREAM CS08651-02 manufactured by Oridion Medical.
[73514326]
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
[73514327]
Medtronic received a report that the unit did not generate an audible alarm. Customer indicated there was no patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5
[77951782]
The sample associated to this report was received and the customer reported issue could not be duplicated.? We are unable to determine the cause for this specific event however, manufacturing controls are in place to detect damage and to reduce the potential for occurrence during the manufacturing process. Information has been added to the database and trends will continue to be monitored. 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
[77951783]
Medtronic received a report that the unit was not alarming, they had no audio. Customer indicated there was no patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8044004-2017-05002 |
| MDR Report Key | 6506494 |
| Date Received | 2017-04-19 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-03-22 |
| Date Mfgr Received | 2017-05-11 |
| Date Added to Maude | 2017-04-19 |
| 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 | ORIDION MEDICAL |
| Manufacturer Street | 7 HAMARPEH ST. |
| Manufacturer City | JERUSALEM 91235 |
| Manufacturer Postal Code | 91235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSTREAM |
| Product Code | MNR |
| Date Received | 2017-04-19 |
| Returned To Mfg | 2017-05-11 |
| Model Number | CS08651-02 |
| Catalog Number | CS08651-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIDION MEDICAL |
| Manufacturer Address | 7 HAMARPEH ST. JERUSALEM 91235 91235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-19 |