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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 Pumping Stopped (1503)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported via a field service report: (b)(4). Symptom: pump had system error #1 alarms and stopped pumping while on patient. Pump switched out quickly. No patient complications. Findings / actions taken: replaced front end board. Software level: (b)(4). Expedited qa review: yes. Confirmed.
 
Manufacturer Narrative
(b)(4). The front end board (p/n: 77-1010-002 s/n: (b)(4)) was returned for evaluation. Visual inspection of fe board was performed and a burnt capacitor c202 was found. The burnt component c202 was caused a short circuit (-12 volts to ground). No further functional testing can be performed on the front end board due to the damage component c202 (-12 volts circuitry). No further testing can be performed due to a short on the circuitry. 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. Conclusion: the reported complaint of "alarm, system error 1" is confirmed. A burnt component c202 was found on the feb and that caused a short in the circuit. The burnt component was the cause of the reported complaint; however, the root cause of the burnt component c202 is undetermined.
 
Event Description
It has been reported via a field service report: (b)(4). Symptom: pump had system error #1 alarms and stopped pumping while on patient. Pump switched out quickly. No patient complications. Findings / actions taken: replaced front end board. Software level: 2. 24. Expedited qa review: yes. 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 Key5844228
MDR Text Key51121998
Report Number1219856-2016-00171
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 07/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2016
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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