FDA Adverse Event Malfunction Summary report: N

ASSY,ENGLISH,DOMSTC,110V,SYS98

MDR report key: 23895200 · Received December 26, 2025

Report

Report Number: 2249723-2025-0005286
Event Type: Malfunction
Date Received: December 26, 2025
Date of Event: December 2, 2025
Report Date: March 16, 2026
Manufacturer: DATASCOPE CORP.
Product Code: DSP
PMA / PMN Number: K961509
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: BIOMEDICAL ENGINEER
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

UPDATED FIELDS: B4, D1, E1 (EVENT SITE TELEPHONE), E3, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: G4 (PMA/510K). FIELDS D1, D4 OF THE EMDR IS FOR THE ORIGINAL PUMP SYSTEM 98; HOWEVER SYSTEM 98 UPGRADED TO CS300, HENCE PMA/510(K) FOR CS300 IS K063525. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT UNABLE TO REPRODUCE THE CODE. AS PER MANUAL, THE FSE REMOVED AND REPLACED THE DRIVER BOARD TO REMEDY THE CODE 58. PERFORMED SYSTEM CHECKOUT AS REQUIRED. COMPLETED REPAIR SUCCESSFULLY. THE PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. RETURNED UNIT TO CUSTOMER FOR USE.

Additional Manufacturer Narrative · 0

SYSTEM 98 UPGRADED TO CS300. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

Description of Event or Problem · 0

N/A.

Description of Event or Problem · 0

IT WAS REPORTED BY THE CUSTOMER THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED ERROR CODE 2 PRIOR TO USE . LOG ANALYSIS REVEALED ELECTRICAL TEST CODE 58 . NO PATIENT INVOLVEMENT OR HARM REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2330173	ASSY,ENGLISH,DOMSTC,110V,SYS98	SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL	DSP	DATASCOPE CORP.	0998-00-0446-53

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown