MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-STEP¿ PACING/ECG/DEFIBRILLATION ELECTRODES; EXTERNAL DEFIBRILLATOR ELECTRODE, ADULT, SINGLE-USE

Catalog Number 99512-000091

Device Problem Failure to Sense (1559)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted stryker to report that their device electrodes could not be recognized by the device.In this state, the need for therapy could not be determined, if it were needed.There was no patient use associated with the reported event.

Manufacturer Narrative

The product assessment center (pac) technician evaluated the electrodes and was able to verify the reported issue.The root cause of the reported issue is determined to be corrupted memory (eeprom) of the electrode tray.The customer received a replacement electrode tray.The customer's electrode tray was archived by stryker.

Event Description

The customer contacted stryker to report that their device electrodes could not be recognized by the device.In this state, the need for therapy could not be determined, if it were needed.There was no patient use associated with the reported event.

• Brand Name: QUIK-STEP¿ PACING/ECG/DEFIBRILLATION ELECTRODES
• Type of Device: EXTERNAL DEFIBRILLATOR ELECTRODE, ADULT, SINGLE-USE
• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18806357
• MDR Text Key: 336524305
• Report Number: 0003015876-2024-00460
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K960329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 99512-000091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• 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: QUIK-STEP¿ ELECTRODES, DRX, (B)(6)