CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2022-00048
- Event Type
- Malfunction
- Date Received
- January 10, 2022
- Date of Event
- December 17, 2021
- Report Date
- October 10, 2022
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE INITIAL REPORTER¿S NAME IS SHORTENED DUE TO FIELD CHARACTER LIMIT. THE FULL NAME IS (B)(6). TESTING OF ACTUAL/SUSPECTED DEVICE ((B)(4)): THE CUSTOMER DID NOT REQUEST SERVICE; HOWEVER, THE CUSTOMER CALLED A GETINGE EMERGENCY REPRESENTATIVE (GER) FOR ASSISTANCE. THE GER GUIDED THE CUSTOMER THROUGH RELOADING THE RESCUE IABP UNIT INTO THE HOSPITAL CART, WHICH RESOLVED THE ISSUE. THE HYBRID ICON AND ELECTRICAL PLUG ICONS WERE NOW VISIBLE. ADDITIONAL INFORMATION IS BEING REQUESTED WITH REGARD TO THE STATUS OF THE IABP. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
THE INITIAL REPORTER¿S NAME IS SHORTENED DUE TO FIELD CHARACTER LIMIT. THE FULL NAME IS (B)(6). THE CUSTOMER DID NOT REQUEST SERVICE; HOWEVER, THE CUSTOMER CALLED A GETINGE EMERGENCY REPRESENTATIVE (GER) FOR ASSISTANCE. THE GER GUIDED THE CUSTOMER THROUGH RELOADING THE RESCUE IABP UNIT INTO THE HOSPITAL CART, WHICH RESOLVED THE ISSUE. THE HYBRID ICON AND ELECTRICAL PLUG ICONS WERE NOW VISIBLE. ADDITIONAL INFORMATION IS BEING REQUESTED WITH REGARD TO THE STATUS OF THE IABP. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: A2, A3, A4, B4, D9, G3, G6, G7, H2, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELD: G1 (CONTACT PERSON ¿ MFG SITE). PATIENT OR PERSON HEIGHT (CM): 180.
IT WAS REPORTED THAT DURING USE WHEN THE PATIENT ARRIVED FROM THE CCL, THE ICU REGISTERED NURSE (RN) PLUGGED IN THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) AND NOTED THAT THE BATTERY WAS STILL IN USE. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED .
IT WAS REPORTED THAT DURING USE WHEN THE PATIENT ARRIVED FROM THE CCL, THE ICU REGISTERED NURSE (RN) PLUGGED IN THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) AND NOTED THAT THE BATTERY WAS STILL IN USE. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED .
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 981876 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | N/A | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male |