MAUDE Adverse Event Report: DATASCOPE CORP. SSYTEM 98; INTRA-AORTIC BALLOON PUMP

Model Number SYSTEM 98

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2013

Event Type  malfunction  

Event Description

The customer reported that a foul odor was coming from the iabp when they entered in the medical engineering room where the unit was being stored.No patient was involved.

Manufacturer Narrative

The device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances in the dhr related to the reported event.The company representative evaluated the unit at the maquet office and found that the battery was deformed and generating heat.The batteries were removed from the unit and were send and received by the manufacturing facility at (b)(6) for evaluation.The evaluation of the batteries is in progress.Because the iabp unit is an old model, we are awaiting for the customer unit disposition.A supplemental medwatch report will be submitted when additional information becomes available.(b)(4).

• Brand Name: SSYTEM 98
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): DATASCOPE CORP.; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: tina evancho, mgr. ; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 3980459
• MDR Text Key: 4748675
• Report Number: 2249723-2014-00794
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYSTEM 98
• Device Catalogue Number: 0998-00-0446-XX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1