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

Model Number CRPLUS

Device Problem Failure to Sense (1559)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.   though stryker requested some patient information, stryker will not request any information which can identify, directly or indirectly, a person to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.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 provided incorrect defibrillation analyze.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

Event Description

The customer contacted stryker to report that their device provided incorrect defibrillation analyze.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

Manufacturer Narrative

A stryker service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.A stryker customer quality engineer reviewed device electronic records and was not able to verify reported issue.The analysis found no issue with the devices decision making based off of the shock algorithm.A cause of the reported issue could not be determined.

• Brand Name: LIFEPAK CR(R) PLUS 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16752181
• MDR Text Key: 313717133
• Report Number: 0003015876-2023-00674
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CRPLUS
• Device Catalogue Number: 99403-000211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 110 KG