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

Catalog Number 3010901-006

Device Problem Connection Problem (2900)

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

Event Date 12/06/2017

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.

Event Description

The customer contacted physio-control to report that their device would not recognize the internal paddles during a patient event.The customer disconnected the internal paddles and connected the therapy cable, which worked.The internal paddles were connected to another device and they were still not recognized.Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer advised that no further details are available.

Manufacturer Narrative

Physio-control evaluated the customer's internal paddles assembly and was unable to duplicate the reported issue.The cause of the reported issue could not be determined.The customer received a replacement for their internal paddles assembly.

• Brand Name: HANDLES AND CONNECTOR WITH DISCHARGE CONTROL
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; redmond WA 98073 9706
• Manufacturer Contact: todd bandy
• MDR Report Key: 7134362
• MDR Text Key: 95745384
• Report Number: 3015876-2017-01631
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3010901-006
• Device Lot Number: 1709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/23/2018
• 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