CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-0004319
- Event Type
- Malfunction
- Date Received
- October 22, 2024
- Date of Event
- October 1, 2024
- Report Date
- July 8, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED FIELD: B4; D8; D9; G1 CONTACT PERSON'S NAME; H2; ; G3; G6; H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, COMPONENT CODE; H11. CORRECTED FIELD: B5; B6; B7; D10; H6 HEATH EFFECT IMPACT CODE. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THEY WERE UNABLE TO REPRODUCE THE FAILURE. THE FSE REPLACED THE POWER MANAGEMENT BOARD (0670-00-1162) DUE TO LOGS CONFIRMING THE SHUT OFF AND SUBSEQUENT POWER ON. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER. THE FOLLOWING INVESTIGATION WAS PERFORMED BY CARL FAMULARE, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ CF 22 JAN 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1162 PCB, POWER MANAGEMENT ROHS SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF WALL TO BATTERY SHUTOFF. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0670-00-1162 PCB, POWER MANAGEMENT ROHS SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT DEPT. INSTALLED A POWER SUPPLY INTO SLOT 1 OF THE CARDIOSAVE CONSOLE AND A BATTERY IN SLOT 2. THE FAT PULLED THE LINE CORD FROM THE POWER SUPPLY, THE CONSOLE TRANSITIONED OVER TO BATTERY. THE FAT THEN INSTALLED THE POWER SUPPLY INTO SLOT 2 OF THE CONSOLE AND A BATTERY IN SLOT 1. THE FAT PULLED THE LINE CORD FROM THE POWER SUPPLY. THE CONSOLE TRANSITIONED OVER TO BATTERY SUPPLY WITH NO PROBLEM FOUND. THE FAT THEN INSTALLED THE CONSOLE INTO THE CARDIOSAVE CART AND PLUGGED THE CART INTO THE WALL. A BATTERY WAS INSTALLED INTO SLOT 1. THE FAT THEN PULLED THE CART LINE CORD FROM THE WALL. THE CARDIOSAVE TRANSITIONED OVER TO BATTERY POWER. THE FAT THEN INSTALLED A BATTERY INTO SLOT 2 OF THE CONSOLE AND PLUGGED THE LINE CORD INTO THE WALL. THE FAT PULLED THE LINE CORD FROM THE WALL, THE CARDIOSAVE TRANSITIONED OVER TO BATTERY POWER WITH NO PROBLEM FOUND. THE FAT COULD NOT REPLICATE THE COMPLAINT OF WALL TO BATTERY SHUTOFF. THE BOARD PASSED TESTING. RETAINING THE BOARD IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D016 REV. AS.
UPDATED FIELDS: B4; G3; G6; H2; H11. CORRECTED FIELDS: D9 RETURN TO MANUFACTURE DATE.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
IT WAS REPORTED THAT AFTER AIR TRANSPORTING THE PATIENT, THE AIRCRAFT WAS SHUT OFF, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUTOFF (IT HAD BEEN RUNNING ON THE PORTABLE SUPPLY). THE OPERATOR POWERED IT BACK ON AND IT CONTINUED TO PUMP ON BATTERY. THERE WAS PATIENT INVOLVEMENT BUT NO HARM OR INJURY.
IT WAS REPORTED THAT AFTER AIR TRANSPORTING THE PATIENT THE AIRCRAFT WAS SHUT OFF, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUTOFF (IT HAD BEEN RUNNING ON THE PORTABLE SUPPLY). THE OPERATOR POWERED IT BACK ON AND IT CONTINUED TO PUMP ON BATTERY. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1924994 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |