MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-17 for IQECG 1-100-1325 manufactured by Midmark Corporation.
Report Number | MW5088200 |
MDR Report Key | 8802873 |
Date Received | 2019-07-17 |
Date of Report | 2019-07-15 |
Date of Event | 2018-01-05 |
Date Added to Maude | 2019-07-18 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | IQECG |
Generic Name | ELECTROCARDIOGRAPH |
Product Code | DPS |
Date Received | 2019-07-17 |
Model Number | 1-100-1325 |
Catalog Number | 1-100-1325 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MIDMARK CORPORATION |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2019-07-17 |