MAUDE Adverse Event Report: PHYSIO-CONTROL, INC QUIK-COMBO(R) ELECTRODES WITH REDI-PAK(R) PRECONNECT SYSTEM; ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION

Catalog Number 11996-000017

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the electrodes and verified that one of the connector pins in the quik-combo connector was bent.Physio continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that they found a pair of quik-combo adult pacing/defibrillation/ecg electrodes with a "twisted" pin in its connector.They had tried to connect the electrodes to a defibrillator to treat a patient.When they found that the electrodes could not be connected, they immediately used a second set of electrodes.The customer stated that the issue with the electrodes did not affect the patient treatment.

Manufacturer Narrative

Physio-control further evaluated the electrodes.It was observed that one of the connector pins in the quik-combo connector was bent, but not because of a manufacturing process.The connector pin was bent from the tip and it appeared that two insertion attempts had been made; the pin was physically damaged. the cause of the reported issue was due one of the connector pins in the quik-combo connector being bent.Further root cause of the pin being bent could not be determined.

• Brand Name: QUIK-COMBO(R) ELECTRODES WITH REDI-PAK(R) PRECONNECT SYSTEM
• Type of Device: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer Contact: todd bandy
• MDR Report Key: 7121459
• MDR Text Key: 95055852
• Report Number: 3015876-2017-01598
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K960329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11996-000017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1