MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW VPS RHYTHM MONITOR BUNDLE - REFURBISHED; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037512
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported their monitor shorted out and started smoking.It will not turn back on.No patient involvement.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Vps rhythm monitor s/n: (b)(6) with accessories was returned.A visual examination revealed all returned items were in acceptable condition with no obvious external defects or anomalies.During functional testing , the returned monitor could be powered on, but while booting, multiple failures occurred during the "start up self tests".Troubleshooting determined the dc-dc convertor showed evidence of heat damage and is causing the multiple failures during the "start up self tests".Information provided by the customer confirmed the t-piece t10197 was used with this unit at the time of this issue.The t-piece was investigated and it was confirmed the lemo (main) cable outer jacket was severely abraded and was exposing the shielding, as well as, the inner conductors.T-piece t10197 was not functionally tested as received as damaged lemo (main) cables have been known to cause damage to the dc-dc convertor in previous similarly reported events.The cause of this event is the damaged lemo (main) cable on t-piece t10197.The damage to the lemo (main) cable on t-piece t10197 is characteristic of unintentional aggressive handling by the user.A device history record review performed on the monitor did not reveal any manufacturing or servicing related issues.Teleflex will continue to monitor and trend reports of this nature.
Event or Problem Description
Customer reported their monitor shorted out and started smoking.It will not turn back on.No patient involvement.

• Brand Name: ARROW VPS RHYTHM MONITOR BUNDLE - REFURBISHED
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14457360
• Report Number: 3011137372-2022-00077
• Device Sequence Number: 17318346
• Product Code: LJS
• UDI-Device Identifier: 10801902127881
• UDI-Public: 10801902127881
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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
• Device Model Number: IPN037512
• Device Catalogue Number: RHY-100-MTRB-R
• Device Lot Number: SERVICE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown