SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
Report
- Report Number
- 2248146-2023-00737
- Event Type
- Malfunction
- Date Received
- December 27, 2023
- Date of Event
- December 9, 2023
- Report Date
- August 29, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K133074
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- 501
Narratives
ADDITIONAL REPORTER: (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID # 943571 H3 OTHER TEXT : DEVICE NOT RETURNED.
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. REFERENCE COMPLAINT: (B)(4).
COMPLAINT RECORD ID #(B)(4).
IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), IT WAS WORKING PROPERLY. HOWEVER, AFTER MOVING THE PATIENT FROM THE TABLE TO THE BED, THE PUMP GENERATED A FIBER OPTIC SENSOR FAILURE ALARM. THE GETINGE REPRESENTATIVE HAD THE CUSTOMER REMOVE AND REINSERT THE FIBER OPTIC SENSOR, BUT THE MESSAGE CONTINUED. IT WAS THEN RECOMMENDED THEY REMOVE THE ORANGE CABLE FROM THE PUMP, COIL IT UP AND MARK IT "BROKEN". THEY WERE THEN ABLE TO TRANSDUCE THE INNER LUMEN TO THE PUMP, LEVEL, AND ZERO IT. THE FOLLOW UP TEXTED IMAGE SHOWED A NORMAL LOOKING NON-FIBEROPTIC WAVEFORM WITH INDICES. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1400751 | SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET) | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0684-00-0576-01 | 3000309868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |