MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-16 for EPIQ 7C - 795201 manufactured by Philips Ultrasound, Inc.
[183550816]
Initial visual inspection by the philips field service engineer identified the bushing in the swivel mechanism to be in an incorrect position. Evaluation of the control panel arm will be included in a follow up report upon its return and investigation completion.
Patient Sequence No: 1, Text Type: N, H10
[183550817]
A customer reported a sonographer was injured while transporting the epiq ultrasound system to the echo lab. Feedback details described the incident as occurring when the swivel mechanism on the control panel arm came loose during transport. The sonographer was seen in the er and her injuries included a back muscle strain and weakening and tingling down her arm. After several attempts, no additional details regarding the patient injury or medical intervention could be obtained. The system remains at the site and was returned to service following the replacement of the control panel arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019216-2020-00019 |
| MDR Report Key | 9835570 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-15 |
| Date of Event | 2019-11-14 |
| Date Mfgr Received | 2019-11-18 |
| Device Manufacturer Date | 2014-06-20 |
| Date Added to Maude | 2020-03-16 |
| 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 | MR. PAUL CORRIGAN |
| Manufacturer Street | 22100 BOTHELL EVERETT HIGHWAY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4254877000 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPIQ 7C - 795201 |
| Generic Name | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22 |
| Product Code | IYN |
| Date Received | 2020-03-16 |
| Model Number | EPIQ 7C - 795201 |
| Catalog Number | EPIQ 7C - 795201 |
| Lot Number | US514B0367 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS ULTRASOUND, INC |
| Manufacturer Address | 22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 US 98021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-16 |