MAUDE Adverse Event Report: PHYSIO-CONTROL, INC HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Catalog Number 3010901

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2015

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 reported that paddle spoon of their internal defibrillation paddles assembly would not lock into place and would fall out.In this condition, the internal paddles could not be used to deliver defibrillation therapy to a patient, if needed.There was no patient use associated with the reported issue.

Manufacturer Narrative

The customer was provided with a replacement internal defibrillation paddle handles assembly and internal paddles (spoons).Physio-control evaluated the customer's internal defibrillation paddle handles assembly but was unable to duplicate the reported issue.The assembly passed both a visual inspection and insertion test.The internal defibrillation paddle handles assembly was tested with all six (6) sets of spoons that the customer returned along with the assembly and it was observe that the shaft of the spoons would move freely inside the handle insert and would lock appropriately in the handle.Additionally, it was observed that the assembly passed all charge and shock tests.The cause of the reported issue could not be determined.

Manufacturer Narrative

Lot number of the follow-up medwatch report should have included - 1501.The follow-up medwatch report should have included a return date of 09/09/2015.

• Brand Name: HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• 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: 4998148
• MDR Text Key: 22832701
• Report Number: 3015876-2015-00963
• 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,u
• Reporter Occupation: Other
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3010901
• Device Lot Number: 1501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/05/2015
• 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