MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-24 for X7-2T TRANSDUCER (MTEE) 989605361911 manufactured by Philips Ultrasound, Inc.
[181392024]
Return of the suspect transducer is anticipated. Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
Patient Sequence No: 1, Text Type: N, H10
[181392025]
A customer reported an articulation issue with an x7-2t model transducer. Problems with the tip movement were reported as being caused by damage to the device. There was no injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019216-2020-00006 |
| MDR Report Key | 9628141 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-24 |
| Date of Report | 2019-12-29 |
| Date Mfgr Received | 2019-12-29 |
| Device Manufacturer Date | 2015-01-27 |
| Date Added to Maude | 2020-01-24 |
| 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 | X7-2T TRANSDUCER (MTEE) |
| Generic Name | TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
| Product Code | ITX |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2020-02-05 |
| Model Number | 989605361911 |
| Lot Number | B18BDN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-24 |