MAUDE Adverse Event Report: PHYSIO-CONTROL, INC HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION; CABLE, ELECTRODE

Catalog Number 11131-000001

Device Problem Failure to Sense (1559)

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

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control advised the customer that the internal paddles should be permanently removed from service.Neither the device nor the internal paddles were returned to physio-control for evaluation.The cause of the reported issue could not be determined.

Event Description

The customer contacted physio-control to report that a set of internal paddles being used in conjunction with their lifepak 20 device would not work during a patient event.The customer was unable to provide any further details about the internal paddles.The customer advised that a backup set of internal paddles were quickly obtained and used to treat the patient.There were no adverse effects to the patient as a result of the reported issue.Physio-control has made multiple attempts to contact the customer in order to obtain additional information about the patient and the event; however, no response has been received.

• Brand Name: HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION
• Type of Device: CABLE, ELECTRODE
• 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
• MDR Report Key: 7046762
• MDR Text Key: 93091075
• Report Number: 3015876-2017-01448
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11131-000001
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1