FDA Adverse Event
Malfunction
Summary report: N
CUSTOM TUBING PACK
MDR report key: 3963275
·
Received June 18, 2014
Report
- Report Number
- 2248146-2014-00099
- Event Type
- Malfunction
- Date Received
- June 18, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 23, 2014
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DWE
- PMA / PMN Number
- K080592
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
UPON INITIATION OF ECLS, THE TRANS-MEMBRANE PRESSURE WAS 60 MMHG; THEY USUALLY SEE THIS NUMBER AT 20-30. OXYGEN PERFORMANCE APPEARED TO BE FINE. NO PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356694 | CUSTOM TUBING PACK | CARDIOPULMONARY DEVICE | DWE | DATASCOPE CORP. | BEQ-TOP 31203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |