MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-19 for ECARECOMPANION 453564551731 manufactured by Visicu, Inc - Dup.
[180760329]
A skin tear occurred while using the device, which required medical intervention and/or additional treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125873-2020-00002 |
| MDR Report Key | 9728684 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-30 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON FISHTER |
| Manufacturer Street | 217 E REDWOOD ST STE 1900 |
| Manufacturer City | BALTIMORE MD 21202 |
| Manufacturer Country | US |
| Manufacturer Postal | 21202 |
| Manufacturer G1 | PHILIPS HEALTHCARE (ALPHARETTA) |
| Manufacturer Street | ONE DEERFIELD CENTER 13560 MORRIS ROAD STE 2100 |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECARECOMPANION |
| Generic Name | ECAD BP MEDIUM/LG |
| Product Code | DRG |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-02-05 |
| Model Number | 453564551731 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISICU, INC - DUP |
| Manufacturer Address | 217 E REDWOOD ST STE 1900 BALTIMORE MD 21202 US 21202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-19 |