MAUDE Adverse Event Report: PHYSIO-CONTROL, INC QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES W/EDGE SYSTEM TECHNOLOGY; ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION

Catalog Number 11996-000091

Device Problem Bent (1059)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.(b)(4).

Event Description

The customer contacted physio-control to report that a set of quik-combo therapy electrodes would not plug into the therapy cable assembly.Medical personnel observed that one of the pins on the connector was off-center, preventing them from plugging into the therapy cable.As a result, defibrillation therapy would not have been possible using these electrodes.The reported issue was observed during an attempt by medical personnel to transcutaneously pace a patient.A second set of therapy electrodes were obtained and used to continue patient care.There were no adverse effects to the patient as a result of the reported issue.The customer advised that due to privacy laws they were unable to provide any information about the patient.

Manufacturer Narrative

Physio-control has contacted the customer multiple times in order to obtain the quik-combo therapy electrodes used during the event returned to physio-control for evaluation; however, the customer is not sure if the electrodes were retained following the event.  the electrodes have not been returned to physio-control for evaluation.The cause of the reported issue could not be determined.

• Brand Name: QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES W/EDGE SYSTEM TECHNOLOGY
• Type of Device: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 4258674000
• MDR Report Key: 6915409
• MDR Text Key: 88225508
• Report Number: 3015876-2017-01239
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2019
• Device Catalogue Number: 11996-000091
• Device Lot Number: 715334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1