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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MFORCE MOTOR DRIVER ASSEMBLY
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ARROW INTERNATIONAL INC. MFORCE MOTOR DRIVER ASSEMBLY Back to Search Results
Catalog Number 33-3025-001
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
There was no patient involvement.It was reported that the mforce was replaced.After the mforce was replaced, the intra-aortic balloon pump (iabp) had a system error 3 alarm when the iabp initiated pumping.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "system error 3 alarm" is confirmed.During the investigation, the returned m-force was installed in a pump and alarmed for "system error 3".A broken connector pin on the motor driver/cpu cable of the m-force was noted and caused the alarms.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.A non-conformance has been initiated to further investigate the issue.
 
Event Description
There was no patient involvement.It was reported that the mforce was replaced.After the mforce was replaced, the intra-aortic balloon pump (iabp) had a system error 3 alarm when the iabp initiated pumping.
 
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Brand Name
MFORCE MOTOR DRIVER ASSEMBLY
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11778771
MDR Text Key252368345
Report Number3010532612-2021-00132
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number33-3025-001
Device Lot Number0002001002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Date Manufacturer Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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