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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE JAPANESE SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE JAPANESE SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500J
Device Problems Low Battery (2584); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of "short battery run time" is confirmed. The battery failed the battery load test during functional testing. A definitive root cause could not be determined but a potential cause of the short battery life is a result of not maintaining the battery. Per the operator's manual, battery life is dependent on usage and maintenance of the battery. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This issue will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that during use, the battery of the pump lasted only for thirty minutes. Therefore, the device was withdrawn. The battery was checked by the distributor and the reported issue was duplicated. The battery was replaced by another one and the device worked without problem, so there is a possibility of battery issue. There was no patient death, serious injury or complications reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during use, the battery of the pump lasted only for thirty minutes. Therefore, the device was withdrawn. The battery was checked by the distributor and the reported issue was duplicated. The battery was replaced by another one and the device worked without problem, so there is a possibility of battery issue. There was no patient death, serious injury or complications reported.
 
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Brand NameAUTOCAT2 WAVE JAPANESE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7197732
MDR Text Key270990490
Report Number2518433-2018-00001
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500J
Other Device ID Number00801902043429
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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