MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VPS RHYTHM MONITOR BUNDLE; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037371
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
Customer indicated their monitor started smoking and is no longer working.No patient involvement reported.
Additional Manufacturer Narrative
Qn# (b)(4).The vps rhythm monitor with accessories was returned.A visual examination revealed all returned items were in acceptable condition and did not reveal any obvious defects or anomalies.It was reported "monitor started smoking is no longer working".During functional testing, the unit in was plugged in, a steady green power led was displayed, however when switched on, there was no indication the unit was trying to power on.Troubleshooting determined the component that isolates the supply on the main board was damaged and causing the reported event.The damage to the board has been known to be caused by a faulty t-piece lemo cable where the connector has come apart and allowed the pins to rotate into incorrect positions when inserted into the monitor.Vps rhythm t-piece was also returned and investigated.A visual examination revealed the t-piece was assembled with "a" cables, and the main cable lemo connector can rotate almost 360 degrees.The pins inside the connector remain in the same relative orientation to the key ridge, so that the pins should still be in the correct orientation when plugged in to the monitor.However, due to the large degree of movement, it is suspected that there is internal damage to the wires, possibly causing a short which would result in the damage seen to the main board on the monitor.Because of the history of this device being used which resulted in terminal damage to the main board, a function test of the t-piece was not conducted using this cable.The applied adhesive bond on the assembled components of the connector body has been defeated by user handling which is allowing the connector to rotate almost 360 degrees.The complaint has been confirmed.Unintentional user error caused or contributed to this event because the damage to the connector on the main cable is characteristic of aggressive handling by the user.A device history record review performed on the unit did not reveal any manufacturing related issues.Teleflex will continue to monitor and trend reports of this nature.
Event or Problem Description
Customer indicated their monitor started smoking and is no longer working.No patient involvement reported.

• Brand Name: ARROW VPS RHYTHM MONITOR BUNDLE
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11776706
• Report Number: 3011137372-2021-00126
• Device Sequence Number: 11547762
• Product Code: LJS
• UDI-Device Identifier: 10801902114652
• UDI-Public: 10801902114652
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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: No Information
• Device Model Number: IPN037371
• Device Catalogue Number: RHY-100-MTRB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1