MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 11131

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

The initial reporter¿s phone number is (b)(6).Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) (b)(4) of the european parliament and of the council.Stryker 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

A customer contacted stryker to report that their device would not deliver defibrillation energy when used with internal paddles.As a result, defibrillation therapy would not be available, if needed.There were no adverse effects to the patient as a result of the reported event.

Manufacturer Narrative

Stryker evaluated the device and internal defibrillation paddles.It was observed that the paddles would not respond to the shock button being pressed and would not deliver energy.The reported issue was verified.There was no issue observed with the device.The internal paddles could not be repaired, so they were returned to the customer without repair and the customer was informed that they had failed.The cause of the reported issue was isolated to the failed/faulty internal paddles, but further root cause could not be determined.

Event Description

A customer contacted stryker to report that their device would not deliver defibrillation energy when used with internal paddles.As a result, defibrillation therapy would not be available, if needed.There were no adverse effects to the patient as a result of the reported event.

Manufacturer Narrative

Section f10/h6 health impact code of the initial mdr indicates no patient involvement section f10/h6 health impact code of the initial mdr should indicate no health consequences or impact.Section a2 age at time of event and date of birth of the initial mdr indicates blank section a2 age at time of event and date of birth of the initial mdr should indicate 73 year(s) and 09/06/1949.Section a3 gender of the initial mdr indicates blank.Section a3 gender of the initial mdr should indicate f.Section a4, weight of the initial mdr indicates blank.Section a4, weight of the initial mdr should indicate 90 kg.Section c3/d10, concomitant product grid indicates blank.Section c3/d10, concomitant product grid should indicate 49605402 - lifepak 20e.

Event Description

A customer contacted stryker to report that their device would not deliver defibrillation energy when used with internal paddles.As a result, defibrillation therapy would not be available, if needed.There were no adverse effects to the patient as a result of the reported event.

• Brand Name: HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16162691
• MDR Text Key: 308074751
• Report Number: 0003015876-2023-00068
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K895379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11131
• Device Catalogue Number: 11131-000001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 49605402 - LIFEPAK 20E.; 49605402 - LIFEPAK 20E.
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 90 KG