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

Catalog Number RHY-100-MTRB

Device Problems Device Damaged Prior to Use (2284); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that when the device is turned on, before the case, the screen went blank and they started smelling something burning inside.

Event Description

The customer reports that when the device is turned on, before the case, the screen went blank and they started smelling something burning inside.

Manufacturer Narrative

(b)(4).One rhythm monitor (serial #(b)(4)) was returned for evaluation.All returned items were in acceptable condition.Vps rhythm monitor and t-piece function test was attempted but could not be completed because the unit would not power on.Based on the reported event the unit was opened and the main board was examined.The dcdc converter showed evidence of heat damage.T-piece t10016 was reported used with the returned monitor.The pins on the connector on the t-piece lemo (main) cable were not in the correct location.The incorrect location of the pins caused an incorrect electrical path causing damage to some of the electrical components on the t-piece pcb.The incorrect location of the pins also caused an incorrect electrical path resulting in the damage to the dcdc convertor on the monitor main board.The incorrect location of the t-piece connector pins appears to be the result of an attempt to reassemble the connector while the t-piece was in the field.A device history record review was performed on the vps rhythm unit and did not reveal any manufacturing related issues.The report the monitor gets hot or is smoking was confirmed by evaluation of the returned rhythm monitor.It was determined that ope rational context caused or contributed to this event because the incorrect location of the connector pins appears to be the result of an attempt to reassemble the connector while the t-piece was in the field.

• Brand Name: ARROW VPS RHYTHM MONITOR BUNDLE
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7597022
• MDR Text Key: 111438120
• Report Number: 3011137372-2018-00165
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K160925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RHY-100-MTRB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1