MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-26 for CARDIOMEMS PATIENT ELECTRONIC SYSTEM CM1100 manufactured by St. Jude Medical, Inc..
[188740593]
The device is included in the error 5 advisory notice issued by abbott on 01 june 2018. The reported event was not replicated during analysis. However, it was confirmed to be caused by an incorrect speed setting on the compact flash.
Patient Sequence No: 1, Text Type: N, H10
[188740594]
It was reported that the patient electronic unit received an error 5 message, which indicates an issue related to temperature and barometric pressure. A replacement unit may resolve the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2020-00128 |
| MDR Report Key | 9886069 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2020-03-26 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | 387 TECHNOLOGY CIRCLE NW SUITE 500 |
| Manufacturer City | ATLANTA GA 30313 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30313 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 3004936110-06/01/18-001R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOMEMS PATIENT ELECTRONIC SYSTEM |
| Generic Name | SYSTEM, HEMODYNAMIC, IMPLANTABLE |
| Product Code | MOM |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-18 |
| Model Number | CM1100 |
| Catalog Number | CM1100 |
| Lot Number | 6118430 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 387 TECHNOLOGY CIRCLE NW SUITE 500 ATLANTA GA 30313 US 30313 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |