MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-11 for SITE-RITE 8 ULTRASOUND 9770500 manufactured by Bard Access Systems.
[183139040]
The device has not been received by the manufacturer for evaluation. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Patient Sequence No: 1, Text Type: N, H10
[183139041]
Per biomed - the scanner is not holding a charge/abrupt shut off when the unit is unplugged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00818 |
| MDR Report Key | 9821001 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-11 |
| 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 | SHELLY GILBERT |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225640 |
| Manufacturer G1 | DYMAX CORP. |
| Manufacturer Street | 141 ZEHNER SCHOOL ROAD |
| Manufacturer City | ZELIENOPLE PA 16063 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 16063 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2243072-10/11/2019-013-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SITE-RITE 8 ULTRASOUND |
| Generic Name | SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC |
| Product Code | IYO |
| Date Received | 2020-03-11 |
| Model Number | 9770500 |
| Catalog Number | 9770500 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |