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

Model Number 0998-00-0800-52

Device Problems Fire (1245); Unintended Collision (1429)

Patient Problem No Code Available (3191)

Event Date 07/29/2016

Event Type  malfunction  

Manufacturer Narrative

The production 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 lithium ion battery are under evaluation by a local vendor's representative and the safety data sheet was provided to the customer. The production 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 lithium ion battery are under evaluation by a local vendor's representative.

Event Description

The customer reported that cardiosave hybrid battery was accidently dropped onto the floor from the top of the console and had a small fire on the battery. The customer is requesting msds information because one of their staff inhaled the fumes. No patient was involved and no adverse event was reported.

Manufacturer Narrative

The parts/components to be investigated are in transit to third party vendor for evaluation.

Event Description

The customer reported that cardiosave hybrid battery was accidently dropped onto the floor from the top of the console and had a small fire on the battery. The customer is requesting msds information because one of their staff inhaled the fumes. No patient was involved and no adverse event was reported.

Manufacturer Narrative

The battery pack was sent to the manufacturer of the battery pack for investigation/evaluation. The investigation concluded the battery failure occurred due to the a drop resulting in a damage to one of the internal cells proximal to the connector side of the battery pack. Impact resulted in a physical damage to the cell that in turn resulted in internal short and venting with small fire. All damage was localized to the only cell involved and adjacent wall of the housing. No other cell in the pack was involved in the venting and fire, all other cells maintained their integrity.

Event Description

The customer reported that cardiosave hybrid battery was accidently dropped onto the floor from the top of the console and had a small fire on the battery. The customer is requesting msds information because one of their staff inhaled the fumes. No patient was involved and no adverse event was reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 5900922
• MDR Text Key: 53920916
• Report Number: 2249723-2016-00025
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Other Device ID Number: CA234740I3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse