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

Model Number	11996
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device would not recognize defibrillation pads were connected.The customer tested device and believes the defibrillation electrodes were the issue.In this state the device would not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.
Additional Manufacturer Narrative
Stryker evaluated the customer's lp 15 device - the electrodes were disposed of at the time of event and therefor not available for evaluation.The reported issue could not be duplicated and the cause could not be determined.After observing proper operation of the lp 15 device through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted stryker to report that their device would not recognize defibrillation pads were connected.The customer tested device and believes the defibrillation electrodes were the issue.In this state the device would not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

• 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: 12954929
• Report Number: 0003015876-2021-02304
• Device Sequence Number: 19912600
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943301
• 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): 01/17/2022

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: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: 11996
• Device Catalogue Number: 11996-000017
• Device Lot Number: 922451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK® 15 DEFIBRILLATOR/MONITOR, MJK, SN (B)(6).
• Patient Sex: Unknown