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

Model Number	IPN000325
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
There was no patient involvement.During service it was found that the intra-aortic balloon pump (iabp) was pumping by full battery for only about 30 minutes.When shutting down the battery, the power was turned off and on several times.As a result, the power supply unit and related wiring cables were replaced.
Additional Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "short battery runtime" is not confirmed.The returned power supply passed visual and functional test specifications.The root cause of the complaint is undetermined.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 risk.This will be monitored for any developing trends.
Event or Problem Description
There was no patient involvement.During service it was found that the intra-aortic balloon pump (iabp) was pumping by full battery for only about 30 minutes.When shutting down the battery, the power was turned off and on several times.As a result, the power supply unit and related wiring cables were replaced.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11779799
• Report Number: 3010532612-2021-00130
• Device Sequence Number: 3659505
• Product Code: DSP
• UDI-Device Identifier: 30801902043420
• UDI-Public: 30801902043420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN000325
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1