MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number	11996-000091
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitations, 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.No response has been received from the customer.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) (b)(4) of the (b)(6) 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 or Problem Description
A customer contacted stryker to report that their defibrillation electrodes were unable to adhere to the patient.In this state the device may not be able to provide defibrillation therapy if it were needed.10 packets of electrodes were opened and found affected during reported event.This issue is patient related; however there was no adverse patient outcome reported.
Event or Problem Description
A customer contacted stryker to report that their defibrillation electrodes were unable to adhere to the patient.In this state the device may not be able to provide defibrillation therapy if it were needed.10 packets of electrodes were opened and found affected during reported event.This issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
Section h10 additional mfg narrative of initial mdr indicates: 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. 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.Section h10 additional mfg narrative of initial mdr should indicate: stryker contacted the customer to request additional information on the patient.The customer informed stryker that no further patient information is available.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.   section d1 product long description of initial mdr indicates: quik-combo¿ electrodes with redi-pak¿ preconnect system.Section d1 product long description of initial mdr should indicate: quik-combo.Section d2a common device name of initial mdr indicates: external pacing/defibrillation/ecg electrodes.Section d2a common device name of initial mdr should indicate: electrode, electrocardiograph.Section d2b product code of initial mdr indicates: mkj.Section d2b product code of initial mdr should indicate: drx.Section d4 model #of initial mdr indicates: na.Section d4 model # of initial mdr should indicate: blank.Stryker evaluated the customer's electrodes at the product assessment center (pac) and was able to verify reported issue.The cause of the reported issue was determined to be likely to the storage conditions of the electrodes.The reported electrodes were sent back to the supplier.The customer has been provided with a replacement electrodes.

• Brand Name: QUIK-COMBO
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• 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: 14120873
• Report Number: 0003015876-2022-00579
• Device Sequence Number: 2277053
• Product Code: DRX
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K960329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11996-000091
• Device Lot Number: 004828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR, MKJ.
• Patient Sex: Unknown