MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Numbness (2415)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

The customer did provide the patient's age and date of birth, however the age at time of event does not align with the date of birth given by the customer.The customer provided the following: age at time of event: (b)(6), date of birth: (b)(6).Pma/510(k) or bla # is left blank since the serial number of the device is unknown.The device was not returned to stryker for evaluation.Stryker performed a clinical review of the reported issue and determined that an adverse event occurred which resulted in serious injury.This was based on information available from the device user.Based on the information reported, the cause of the reported issue was due to user error.

Event Description

The customer contacted stryker to report that their device shocked the user when defibrillating a patient.The following was reported by the user that was shocked, "during high performance cpr using an lp15.I had my right hand/fingers monitoring the patients right femoral artery and my left hand was on the lp15.25 minutes into it, someone else came up and pushed the shock button without stating or making sure everyone was clear and i felt the shock hit my right hand.Not a product issue or failure, an operator error that they have admitted to." the customer has also reported the following, "we now know that the shock caused scar tissue in my fascia that causes pain and weakness as it healed and shrink." the user is receiving physical therapy and permanent damage cannot be ruled out.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 13578190
• MDR Text Key: 285943961
• Report Number: 0003015876-2022-00253
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873871713
• UDI-Public: 00883873871713
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2022
• Initial Date FDA Received: 02/22/2022
• 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
• Patient Outcome(s): Disability
• Patient Sex: Male
• Patient Weight: 84 KG