MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-18 for TEE FLEXIBLE PROBE T6H * manufactured by Philips.
[3134001]
This patient was in the ep lab for a planned transesophageal transcardiogram (tee)/cardioversion. Per the investigation/interview with bioengineering, and the tee tech, the philips tee flexible probe was passed and the procedure began. The philips ie33 us machine (the brain) gave an error message and froze. The machine was restarted, however the probe could not be autocalibrated. Another probe was brought in and the procedure was successfully completed without any injury/harm to the patient. Please note the probe was a loaner from medrad mvs. Bioengineering inspected the probe and noted a significant "dent" at the proximal portion of the probe. It is unclear how the damage occurred. Medrad rep was contacted. The probe was returned to medrad. What was the original intended procedure? Tee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2994113 |
| MDR Report Key | 2994113 |
| Date Received | 2013-02-18 |
| Date of Report | 2013-02-18 |
| Date of Event | 2013-02-13 |
| Report Date | 2013-02-18 |
| Date Reported to FDA | 2013-02-18 |
| Date Reported to Mfgr | 2013-03-08 |
| Date Added to Maude | 2013-03-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TEE FLEXIBLE PROBE |
| Generic Name | PROBE, CATHETER, ESOPHAGEAL |
| Product Code | BZT |
| Date Received | 2013-02-18 |
| Model Number | T6H |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS |
| Manufacturer Address | 3000 MINUTE MAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-18 |