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

Catalog Number 3010901

Device Problem Failure to Deliver Energy (1211)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The internal paddles assembly has not been returned to physio-control for evaluation.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.

Event Description

The customer reported that during a patient event, their internal defibrillation paddles failed to deliver a defibrillation shock.The customer indicated that they were able to charge the defibrillation energy and when the shock button was pressed on the handles, nothing happened.They were able to use a backup set of internal defibrillation paddles and deliver energy successfully.There was no additional information provided on the patient or the event.It is unknown if the patient suffered any adverse effects as a result of the reported issue.

Manufacturer Narrative

The customer advised physio-control that they have replaced the internal defibrillation paddles assembly.The faulty set of paddles will not be returned to physio-control for evaluation.The cause of the reported issue could not be determined.

• Brand Name: HANDLES AND CONNECTOR WITH DISCHARGE CONTROL
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 5307182
• MDR Text Key: 33784213
• Report Number: 3015876-2015-01544
• Device Sequence Number: 1
• Product Code: IKD
• 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,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3010901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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