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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL LLC AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500I
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
Event Description
It was reported " alarm: low battery also connected to the electricity mains" it is reported that the defect was discovered during identified during incoming inspection/inventory review.No patient involvement reported.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Qn#(b)(4).The reported complaint of "low battery alarm even connected to ac" was not able to be confirmed as no part or recorder strip was returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
It was reported " alarm: low battery also connected to the electricity mains" it is reported that the defect was discovered during identified during incoming inspection/inventory review.No patient involvement reported.
 
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Brand Name
AUTOCAT2 WAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville 27560
MDR Report Key18672295
MDR Text Key334981016
Report Number3010532612-2024-00103
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberIAP-0500I
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
N/A.; N/A.
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