FDA Adverse Event Malfunction Summary report: N

CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

MDR report key: 21342104 · Received February 10, 2025

Report

Report Number: 2249723-2025-0000610
Event Type: Malfunction
Date Received: February 10, 2025
Date of Event: January 22, 2025
Report Date: July 3, 2025
Manufacturer: DATASCOPE CORP.
Product Code: DSP
UDI-DI: 10607567107295
PMA / PMN Number: K031636
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TH
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

DUE TO CHARACTER LIMIT IN THE E1 SECTION INITIAL REPORTER NAME, THE FULL INITIAL REPORTER'S NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE COMPLETION OF INVESTIGATION.

Additional Manufacturer Narrative · 0

CORRECTED FIELDS: G3- IN THE MFG REPORT NUMBER. 2249723-2025-0000610, MFG FOLLOW-UP # 1 THE FIELD "DATE RECEIVED BY MFG" WAS INCORRECTLY CAPTURED I.E. 08-04-2025. THE CORRECT "DATE RECEIVED BY MFG" IS 02-07-2025. UPDATED FIELDS: B4, G3, H2, H11.

Additional Manufacturer Narrative · 0

UPDATED FIELDS: B4, G3, G6, H2, H11. UPON FURTHER REVIEW IT WAS DETERMINED THAT THE REPORTED EVENT INVOLVED ONLY ROUTINE MAINTENANCE. THERE WAS NO MALFUNCTION OF THE DEVICE AND THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL IN YOUR DATABASE.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE CS100 INTRA AORTIC BALLOON PUMP HAD A MAINTENANCE KIT RELATED MALFUNCTION, IDENTIFIED DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
836689	CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V	SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL	DSP	DATASCOPE CORP.	0998-00-3013-55		10607567107295

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown