MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY; EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES

Catalog Number 11996-000091

Device Problem Device Sensing Problem (2917)

Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

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.Per medwatch report (reference report number mw5107075), patient information is not releasable.The device nor the electrodes were returned to stryker for evaluation.The cause of the reported issue could not be determined.

Event Description

Stryker was notified that the customer submitted a voluntary medwatch report (reference report number mw5107075).The following was reported: "defibrillator pads were applied to patient and were going to be used as initial assessment of rhythm; however, pads did not pick up rhythm.2 sets of defibrillator pads did not function correctly." this mdr is for the second electrodes used.The medwatch report from the customer indicates intervention was required.However, the description of event has no evidence of an adverse patient outcome.

Manufacturer Narrative

The customer provided patient and updated information.Section a, fields a1, a2, and a3; section b field b5 and section d field c2/d10 concomitant product have been updated.

Event Description

Stryker was notified that the customer submitted a voluntary medwatch report (reference report number mw5107075).The following was reported: "defibrillator pads were applied to patient and were going to be used as initial assessment of rhythm; however, pads did not pick up rhythm.2 sets of defibrillator pads did not function correctly." the patient was in asystole and no shock was required.This mdr is for the second electrodes used.The customer reported that the patient did pass away.The customer confirmed that there was no injuries to the patient as a result of the equipment failure.The issue was strictly with the pads and not other associated equipment.The patient did pass away but there were extenuating circumstances that led or caused the patient to pass away per physician notes.

• Brand Name: QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY
• Type of Device: EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES
• 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: 13897363
• MDR Text Key: 288015048
• Report Number: 0003015876-2022-00430
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943301
• 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,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11996-000091
• Device Lot Number: 0305019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LP20E SN (B)(4)
• Patient Age: 68 YR
• Patient Sex: Female