MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY MCT 1L MCT 1L: UNIVERSAL GATEWAY manufactured by Lifewatch Services, Inc..
| Report Number | 3027765-2020-00003 |
| MDR Report Key | 9885388 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-02 |
| 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 | MS. TAHNEE MEHTA |
| Manufacturer Street | 10255 W HIGGINS RD. SUITE 700 |
| Manufacturer City | ROSEMONT, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 5312011 |
| Manufacturer G1 | LIFEWATCH SERVICES, INC. |
| Manufacturer Street | 10255 W HIGGINS RD. SUITE 700 |
| Manufacturer City | ROSEMONT, IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY |
| Generic Name | LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY |
| Product Code | DSI |
| Date Received | 2020-03-26 |
| Model Number | MCT 1L |
| Catalog Number | MCT 1L: UNIVERSAL GATEWAY |
| Lot Number | UNKNOWN/UNREPORTED |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFEWATCH SERVICES, INC. |
| Manufacturer Address | 10255 W HIGGINS RD. SUITE 700 ROSEMONT, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |