MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES); Internal defibrillator electrode, adult and pediatric

Model Number	INTERNAL PADDLES
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer received a replacement set of paddles.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.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.
Event or Problem Description
The customer contacted stryker to report that their device's internal paddles did not deliver a shock.A 2nd set was used to deliver the shock.In this state the device may not be able to deliver defibrillation therapy if needed this issue is patient related; however there was no adverse event reported.

• Brand Name: LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
• Common Device Name: Internal defibrillator electrode, adult and pediatric
• 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 ; +1(425)867-4000
• MDR Report Key: 25298632
• Report Number: 0003015876-2026-01075
• Device Sequence Number: 9422572
• Product Code: LDD
• UDI-Device Identifier: 00883873863497
• UDI-Public: 00883873863497
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K895379
• 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): 08/05/2026

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 Model Number: INTERNAL PADDLES
• Device Catalogue Number: 11131-000045
• Device Lot Number: 012945
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown