MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-11 for TRANSDUCER X8-2T 989605455171 manufactured by Philips Ultrasound, Inc.
[182632962]
The customer declined a replacement and the transducer remains at the user facility. Since the device was not returned, no failure analysis could be performed. The suspect transducer remains at the customer site with no return anticipated.
Patient Sequence No: 1, Text Type: N, H10
[182632963]
A customer reported a loss of articulation with their x8-2t model transducer. There was no injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019216-2020-00009 |
| MDR Report Key | 9693960 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2018-07-18 |
| Date Added to Maude | 2020-02-11 |
| 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 | 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 | TRANSDUCER X8-2T |
| Generic Name | TRANSDUCER |
| Product Code | ITX |
| Date Received | 2020-02-11 |
| Model Number | 989605455171 |
| Lot Number | B2JHZK |
| 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 | 2020-02-11 |