MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH PRODUCT NOT IN LIST - IABP ACCESSORY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	N/A
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lead wires were requested to be returned to getinge's national repair center (nrc) for failure investigation.A supplemental report will be submitted when additional information is provided.
Event or Problem Description
It was reported by a getinge clinical support specialist.During testing and verification of eight (8) sets of esis leads wires, two(2) sets of wires were bad.One of the bad wires belongs to initial issue reported in complaint (b)(4).Subsequently, at the end of testing, one (1) additional lead wire was found.Out of the eight esis lead wires tested, 5 good ones were attached to the iabps and the other 3 are part of the ones for a back up.Since two were bad are part of the back up stets, we were informed that they will be replaced.For the second bad esos fond, there was no patient involvement, and no adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cable, ecg lead, or,5l,aami was returned to the manufacturer for further evaluation.A senior repair technician of the national repair center (nrc) inspected the lead cable with no visual damaged observed.The technician installed the leads into the ecg trunk cable and tested the leads to factory specifications.The technician verified the failure of the leads being defective.An ecg was not able to be established.The leads failed testing.The leads will be retained in the nrc per procedure.H3 other text : n/a.
Event or Problem Description
N/a.

• Brand Name: PRODUCT NOT IN LIST - IABP ACCESSORY
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11379412
• Report Number: 2249723-2021-00407
• Device Sequence Number: 3785962
• Product Code: DSP
• UDI-Device Identifier: 10607567112251
• UDI-Public: 10607567112251
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 0012-00-1814-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 08/02/2021; 02/16/2023
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 08/26/2021; 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown