MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-29 for AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM 989605416151 manufactured by Philips Ultrasound, Inc.
[143668625]
An investigation is underway to determine the root cause of the issue. Results of the investigation will be included in a follow up report upon its completion. Data provided by the customer is being analyzed. An investigation is underway to determine the root cause of the issue.
Patient Sequence No: 1, Text Type: N, H10
[143668626]
A customer reported encountering an incident where images from a current patient study were mixed with a different patient? S exam. The data mix-up was identified by the user and there was no allegation of altered patient outcome as a result of the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019216-2019-00020 |
| MDR Report Key | 8561346 |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-03 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-04-29 |
| 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 | 0 |
| Brand Name | AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM |
| Generic Name | SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC |
| Product Code | IYN |
| Date Received | 2019-04-29 |
| Model Number | 989605416151 |
| Lot Number | US918F0900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-04-29 |