MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-17 for X72T TRANSESOPHAGEAL TRANSDUCER X7-2T TEE manufactured by Philips Medical Systems.
[20781943]
Patient was admitted with mitral valve disease for coronary artery bypass graft and mitral valve replacement. A post-op 2-d transesophageal echocardiogram was performed in surgery. During the procedure, the tee probe lost full movement function. The probe would not rotate to scan different planes. The cardiologist was able to obtain limited views. The patient was not harmed by the equipment malfunction. The tee intraoperative was performed to assess the prosthetic mitral valve function. The prosthetic mitral valve is well-seated. The patient had a permanent pacemaker placed approximately 6 days later and remains hospitalized for recovery. There have been no complications. Biotech did non-destructive testing on the ultrasound unit, which is functioning normally and was returned to service. The tee probe remains in sequester at the hospital. The probe shows no visible damage. ======================manufacturer response for transesophageal echocardiogram probe, philips transesophageal probe (per site reporter). ======================manufacturer will do non-destructive testing to evaluate the tee probe as soon as a memo of understanding is signed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4169256 |
| MDR Report Key | 4169256 |
| Date Received | 2014-09-17 |
| Date of Report | 2014-09-17 |
| Date of Event | 2014-09-09 |
| Report Date | 2014-09-17 |
| Date Reported to FDA | 2014-09-17 |
| Date Reported to Mfgr | 2014-10-14 |
| Date Added to Maude | 2014-10-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X72T TRANSESOPHAGEAL TRANSDUCER |
| Generic Name | TRANSESOPHAGEAL ECHOCARDIOGRAM PROBE |
| Product Code | JOP |
| Date Received | 2014-09-17 |
| Model Number | X72T |
| Catalog Number | X7-2T TEE |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-17 |