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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
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.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, 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 Key5900922
MDR Text Key53920916
Report Number2249723-2016-00025
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K112372
Number of Events Reported1
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 Received08/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-52
Device Catalogue Number0998-00-0800-52
Other Device ID NumberCA234740I3
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 Received09/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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