CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
Report
- Report Number
- 2249723-2025-0002546
- Event Type
- Malfunction
- Date Received
- June 10, 2025
- Date of Event
- May 28, 2025
- Report Date
- September 2, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108575
- PMA / PMN Number
- K063525
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED FIELD- B4, G3, G6, H2, H11. CORRECTED FIELD- H6- COMPONENT CODES.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FILED: B4, G3, G6 AND H11. CORRECTED FIELDS: D9, H3, H6 (MEDICAL DEVICE ¿ PROBLEM CODE AND INVESTIGATION FINDINGS).
UPDATED FILED: B4, D8, D9, E2, E3, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS) AND H11. A GETINGE FIELD SERVICE ENGINEER (FSE) AFTER CHECKING, FOUND THAT THE 5000H KIT EXPIRED NEEDS TO BE REPLACED. THIRD PARTY HAD NOT ACCEPTED THE QUOTE. NO OTHER INFORMATION AVAILABLE. IN FUTURE IF WE RECEIVE ANY REPAIR INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION.
UPDATED FIELDS: B4, G1(CONTACT PERSON ¿ MFG SITE), D8 (DEVICE SERVICED BY THIRD PARTY), D9 (DEVICE AVAILABLE FOR EVAL), G3, G6, H2, H3, H6(INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: G6 (WHILE SUBMITTING THE INITIAL EMDR (2249723-2025-0002546), THE TYPE OF REPORT WAS MARKED AS INITIAL AND 7 DAYS. WHICH WAS ADDED MISTAKENLY HOWEVER CORRECT TYPE OF REPORT WAS 30 DAYS). A GETINGE FIELD SERVICE ENGINEER (FSE) INSPECTED ON-SITE AT THE HOSPITAL TO CONFIRM THE REPORTED FAULT. AFTER CHECKING, FOUND THAT THE 5000H KIT EXPIRED NEEDS TO BE REPLACED. A LEAK WAS DISCOVERED IN THE DRIVE VALVE ASSEMBLY AFTER REPLACING THE 5000-HOUR MAINTENANCE KIT. FSE REPLACED THE DRIVE VALVE ASSEMBLY. THE DEVICE PASSED ALL FACTORY-SPECIFIED PERFORMANCE AND SAFETY TESTS. THE DEVICE HAD BEEN DELIVERED TO THE CUSTOMER AND WAS READY FOR CLINICAL USE.
N/A
IT WAS REPORTED THAT THE DURING USE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD THE DEVICE ALARM FAILED TO AUTOMATICALLY INFLATE, AND OTHER DEVICES WERE PROMPTLY REPLACED, AND NO PERSONAL INJURY WAS CAUSED.
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1265856 | CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-3023-45 | 10607567108575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | IAB |