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

Catalog Number 3010901

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2014

Event Type  malfunction  

Manufacturer Narrative

Correction information: serial number of the initial medwatch report indicates - (b)(4).Serial number of the initial medwatch report should indicate - (b)(4).Supplemental information: physio-control evaluated the removed internal defibrillation paddles assembly and observed that they did function properly.Additionally it was observed that the cover of the shock button on the paddles had a split in it, but still functioned.The split in the cover likely occurred as a result of the sterilization process.

Event Description

The customer reported that the button on their internal defibrillation paddle assembly was broken and would not function in order to deliver defibrillation therapy.There was no patient use associated with the reported issue.

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.

• 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; po box 97006; redmond WA 98073 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 3743973
• MDR Text Key: 11785372
• Report Number: 3015876-2014-00413
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K895379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Device Age: 7 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2014
• 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