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

Catalog Number 3010901-007

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's internal defibrillation paddles cable assembly and verified the reported issue.It was determined that the cause of the reported issue was due to damage on the return spring, which is located inside of the device locking collar.It would not rotate more than 1/8 inch and could not be locked into a device.The customer received a replacement cable assembly.

Event Description

The customer contacted physio-control to report that their internal defibrillation paddles cable assembly would not connect to the mating device connector.A back up cable was able to successfully connect to the defibrillator.There was no patient use associated with the reported event.

• Brand Name: HANDLES AND CONNECTOR WITH DISCHARGE CONTROL
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• 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 ; 4258674000
• MDR Report Key: 6681912
• MDR Text Key: 79123591
• Report Number: 3015876-2017-00816
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2017

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: 3010901-007
• Device Lot Number: 1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: 5 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/30/2017
• 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