FDA Adverse Event Malfunction Summary report: N

CARDIOSAVE HYBRID, TYPE B PLUG

MDR report key: 22882152 · Received August 25, 2025

Report

Report Number: 2249723-2025-0003578
Event Type: Malfunction
Date Received: August 25, 2025
Date of Event: July 28, 2025
Report Date: October 22, 2025
Manufacturer: DATASCOPE CORP.
Product Code: DSP
UDI-DI: 10607567108391
PMA / PMN Number: K112372
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: BIOMEDICAL ENGINEER
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

UPDATED FIELDS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: H11. DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1. EVENT SITE ADDRESS: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE WAS UNABLE TO REPLICATE THE ISSUE WITH A FIBER-OPTIC TEST MANIFOLD. A SMALL AMOUNT OF BLOOD WAS DISCOVERED ON THE PIM EXTERNALLY. THIS WAS CLEANED BY THE STAFF. THERE WAS NO BLOOD INTRUSION FOUND. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER.

Additional Manufacturer Narrative · 0

DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- INITIAL REPORTER- (B)(6). EVENT SITE NAME- (B)(6) FACILITY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

Description of Event or Problem · 0

IT WAS REPORTED THAT CARDIOSAVE INTRA AORTIC BALLOON (IABP), FIBER OPTIC WAS NOT WORKING. THERE WAS NO HARM OR INJURY REPORTED TO PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2291925	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		UNKNOWN.