MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-01-02 for ESAOTE PA230E 96000165000 manufactured by Esaote Europe B.v..
[19296611]
On (b)(6) 2013, esaote europe bv was notified by esaote (b)(4) that they received a complaint from a remanufacturer of an esaote cardiac probe, pa230e. The probe heated excessively during a scan of a difficult to image pt. There was no reported injury to the pt or user.
Patient Sequence No: 1, Text Type: D, B5
[19388093]
As esaote, (b)(4) is the original manufacturer, the unit involved in the report has been evaluated by esaote, (b)(4). Evaluation results from esaote indicate the device are at the upper limit of specifications. If the units at the upper limit of specifications increase the power to the allowed maximum, in combination with specific settings to scan difficult to image pts, probes at the upper limit of specifications may exceed temperature limits at the surface. This results in the possibility of a pt experiencing some discomfort. Esaote europe bv as part of the esaote group has sold the pa230 together with several scanners in the usa. There are more than (b)(4) transducers in the field over a period of 10 years and esaote (b)(4) and esaote europe bv have not received any similar complaint. In order to increase the safety margin to ensure that the temperature limit will not be exceeded by transducers at the upper limit of specifications, esaote europe bv will be issuing a non-mandatory software upgrade within q1 2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610966-2014-00001 |
| MDR Report Key | 3767037 |
| Report Source | 00 |
| Date Received | 2014-01-02 |
| Date of Report | 2014-01-02 |
| Date of Event | 2013-09-08 |
| Date Mfgr Received | 2013-12-16 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2014-05-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BERT VORSTENBOSCH, MGR |
| Manufacturer Street | PHILIPSWEG 1 |
| Manufacturer City | MAASTRICHT 6227AJ |
| Manufacturer Country | NL |
| Manufacturer Postal | 6227 AJ |
| Manufacturer Phone | 33824279 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESAOTE |
| Generic Name | ULTRASONIC DIAGNOSTIC TRANSDUCER |
| Product Code | FTY |
| Date Received | 2014-01-02 |
| Returned To Mfg | 2013-11-19 |
| Model Number | PA230E |
| Catalog Number | 96000165000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ESAOTE EUROPE B.V. |
| Manufacturer Address | PHILIPSWEG 1 MAASTRICHT 6227AJ NL 6227AJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-02 |