MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-20 for SPIDERVIEW manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[145973250]
The subject holter was sent back for repair, because a burn of the size of the sensor was reportedly observed on the patient's chest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2019-00280 |
| MDR Report Key | 8623168 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-20 |
| Date of Report | 2019-08-07 |
| Date of Event | 2019-04-05 |
| Date Facility Aware | 2019-04-26 |
| Date Mfgr Received | 2019-07-15 |
| Date Added to Maude | 2019-05-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELODIE VINCENT |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer Phone | 0146013665 |
| Manufacturer G1 | ASICA ZAC DE LA MOINERIE 35400 SAINT MALO FRANCE |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPIDERVIEW |
| Generic Name | ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) |
| Product Code | MWJ |
| Date Received | 2019-05-20 |
| Returned To Mfg | 2019-04-29 |
| Model Number | SPIDERVIEW |
| Catalog Number | SPIDERVIEW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| Manufacturer Address | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR . CLAMART 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-20 |