P8-2TS
Report
- Report Number
- 3009156722-2026-00006
- Event Type
- Death
- Date Received
- April 8, 2026
- Date of Event
- March 13, 2026
- Report Date
- May 8, 2026
- Manufacturer
- SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
- Product Code
- JOP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE PROBE HAS BEEN RECEIVED AND IS UNDER EVALUATION.
THE REPORTED ISSUE IS UNDER INVESTIGATION PENDING THE RETURN OF THE TRANSDUCER FOR EVALUATION.
IT WAS REPORTED THAT, DURING USE ON A PATIENT IN CARDIAC ARREST, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE STARTED TO VIBRATE AND DID NOT GENERATE AN IMAGE. THE PROBE WAS REMOVED FROM THE PATIENT AND VISUALLY INSPECTED. NO OBVIOUS DAMAGE WAS OBSERVED AND THE PROBE CONTINUED TO VIBRATE. THE USER DISCONTINUED USE OF THE PROBE AND SWITCHED TO A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PROBE TO CONTINUE ASSESSMENT OF THE PATIENT. ON 4/10/2026 IT WAS REPORTED THAT THE PATIENT EXPIRED.
IT WAS REPORTED THAT, DURING USE ON A PATIENT IN CARDIAC ARREST, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE STARTED TO VIBRATE AND DID NOT GENERATE AN IMAGE. THE PROBE WAS REMOVED FROM THE PATIENT AND VISUALLY INSPECTED. NO OBVIOUS DAMAGE WAS OBSERVED AND THE PROBE CONTINUED TO VIBRATE. THE USER DISCONTINUED USE OF THE PROBE AND SWITCHED TO A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PROBE TO CONTINUE ASSESSMENT OF THE PATIENT. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39014 | P8-2TS | P8-2TS PHASED ARRAY TRANSDUCER(TEE) | JOP | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | 120-021851-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| D |