MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	CR2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device was missing the magnet from the lid of the device.In this state the device will not turn on automatically when the lid is activated, which can cause a delay in defibrillation therapy if needed or may lead to use error resulting in a failure to deliver defibrillation.There was no patient use reported with the event.
Additional Manufacturer Narrative
The customer has been provided with a replacement lid.The device nor the lid was returned to stryker for evaluation.An engineering investigation has determined that due to the design of the lpcr2 lid switch, absence of the lid magnet allows current to flow from the battery, even when the device is in standby mode.This will reduce the life of the battery.Therefore, the reported issue, the loss of lid/lid magnet, is associated with two hazardous situations: opening the lid does not turn on the device, and, higher than intended current draw while the device is in standby mode results in a prematurely depleted the battery.Replacement of the device lid so that the magnet is present in the device allows the lid switch to function as designed; turning on/off the device when the lid is opened and preventing current draw when the device lid is closed.The lpcr2 operating instructions has been updated to include additional troubleshooting tips to direct the customer to act when device behavior indicates the lid magnet may be missing.A new warning informs the customer of the risk associated with a missing magnet.H3 other text : not returned to manufacturer.
Event or Problem Description
The customer contacted stryker to report that their device was missing the magnet from the lid of the device.In this state the device will not turn on automatically when the lid is activated, which can cause a delay in defibrillation therapy if needed or may lead to use error resulting in a failure to deliver defibrillation.There was no patient use reported with the event.
Additional Manufacturer Narrative
The initial medwatch report , mfr report # 0003015876-2023-02023 was submitted associating the complaint with correction/removal rpt number 3015876-01/14/2021-001-c.However this device had previously been reported to be part of this pfa under medwatch report mfr report # 0003015876-2023-01329.In the course of that investigation a new lid was provided to the customer.This replacement lid is not associated with correction/removal rpt number 3015876-01/14/2021-001-c, therefore this complaint in mfr report # 0003015876-2023-02023 was submitted incorrectly.Section h6 of the initial medwatch report (mfr report #0003015876-2023-02023) indicates: method code grid - analysis of production records; results code grid - mechanical problem identified.Conclusion code grid - cause traced to component failure.Section h6 of the initial medwatch report (mfr report #0003015876-2023-02023) should indicate: method code grid - device not returned; results code grid - no findings available; conclusion code grid - cause not established.Section h7 of the initial medwatch report (mfr report #0003015876-2023-02023) indicates: remedial action initiated - recall.Section h7 of the initial medwatch report (mfr report #0003015876-2023-02023) should indicate: remedial action initiated - blank.Section h9 of the initial medwatch report (mfr report #0003015876-2023-02023) indicates: correction/removal rpt number - 3015876-01/14/2021-001-c.Section h9 of the initial medwatch report (mfr report #0003015876-2023-02023) should indicate: correction/removal rpt number - blank.Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2023-02023) indicates: the customer has been provided with a replacement lid.The device nor the lid was returned to stryker for evaluation.An engineering investigation has determined that due to the design of the lpcr2 lid switch, absence of the lid magnet allows current to flow from the battery, even when the device is in standby mode.This will reduce the life of the battery.Therefore, the reported issue, the loss of lid/lid magnet, is associated with two hazardous situations: opening the lid does not turn on the device, and, higher than intended current draw while the device is in standby mode results in a prematurely depleted the battery.Replacement of the device lid so that the magnet is present in the device allows the lid switch to function as designed; turning on/off the device when the lid is opened and preventing current draw when the device lid is closed.The lpcr2 operating instructions has been updated to include additional troubleshooting tips to direct the customer to act when device behavior indicates the lid magnet may be missing.A new warning informs the customer of the risk associated with a missing magnet.Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2023-02023) should indicate: the customer has been provided with a replacement lid.The device was not returned to stryker for evaluation.The root cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) CR2 DEFIBRILLATOR
• Common Device Name: 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: 18044444
• Report Number: 0003015876-2023-02023
• Device Sequence Number: 7499806
• Product Code: MKJ
• UDI-Device Identifier: 00883873824092
• UDI-Public: 00883873824092
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P170018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015876-01/14/2021-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown