MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number UNKNOWN

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined (4118): a supplemental report will be submitted if additional information is provided.

Event Description

It was reported that the biomedical engineer (biomed) order two batteries; however one of the batteries received will not charge.The biomed stated that while looking under "power parameters" in the advanced diagnostic screen, the battery showed a manufacture date 1980/00/01, battery temperature of 128 c, a charge cycle count of 0, and no other information.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The lithium ion battery was received at the national repair center (nrc) and was sent to sustaining / r&d for failure investigation.A supplemental report will be submitted if additional information is provided.

Manufacturer Narrative

Testing of actual/suspected device (10) part evaluation performed by getinge sustaining engineering.In order to reproduce the failure, the suspect battery was installed in the cardiosave charging station and fully recharge.The battery was installed in the cardiosave test fixture and pumped at 120 bpm until the battery discharged.The suspect battery was installed in the cardiosave charging station and recharge successfully.Since there was no patient involved and no adverse event was reported; as per our process the battery will be stored in our secure area for 30 days after the investigation is closed.A supplemental report will be submitted upon completion of our investigation.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12346595
• MDR Text Key: 267431443
• Report Number: 2249723-2021-01862
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1