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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problem Failure to Charge (1085)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a field service report: (b)(4). Symptom: no power from power supply. User ran pump but was on battery power until shut off. Pump swapped quickly and did not harm patient. Findings/action taken: found, while plugged in, indictor lights not on, no fans running, and no charging voltage. Checked fuse, all connections, ac input module, all did not fix problem. Replaced power supply. Found battery was at 12. 37v, new charging normally at 13. 34v. Performed functional checklist. Iabp perform to spec. Fcn level: 16, software level: 2. 24. Op
=
on patient, confirmed.
 
Manufacturer Narrative
Qn#(b)(4). The condor power supply (p/n: 77-0063-001 s/n: (b)(4)) was returned for evaluation. Visual inspection of condor power supply was performed and found no obvious damage or defects. The condor power supply was installed into a known good autocat2w and functional testing was performed. The ac was not present and no light indicators were not lid up when the pump was turned on. The pump was also alarmed "system running on battery power". A power supply voltage check was performed per autocat2 series service manual (rev 3) and all voltages were within specification. The pump was run on battery until it shut down. Then let the pump charge for over 9 hours. The pump then failed to turn on. The condor power supply failed all functional testing. A power supply voltage check was performed per autocat2 series service manual (rev 3) and failed voltages check. All output voltages were measured at 0 volt. See other remarks section. Other remarks: visual inspection of the condor power supply internal hardware was performed and no component damage or defects were noted. This is condor power supply was replaced on january 4th, 2005. Conclusion: the reported complaint of "no power from power supply" is confirmed. The reported problem was reproduced during the functional test. The power supply failed functional testing. The cause of the reported power supply malfunction is undetermined.
 
Event Description
It was reported via a field service report: (b)(4). Symptom: no power from power supply. User ran pump but was on battery power until shut off. Pump swapped quickly and did not harm patient. Findings/action taken: found, while plugged in, indictor lights not on, no fans running, and no charging voltage. Checked fuse, all connections, ac input module, all did not fix problem. Replaced power supply. Found battery was at 12. 37v, new charging normally at 13. 34v. Performed functional checklist. Iabp perform to spec. Fcn level: 16, software level: 2. 24. Op
=
on patient, confirmed.
 
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Brand NameAUTOCAT2 WAVE
Type of DeviceINTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5950814
MDR Text Key54763517
Report Number1219856-2016-00207
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot Number0001102349
Other Device ID Number30801902051715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2003
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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