MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUICK 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	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control 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 physio-control to report that their electrodes did not work when connected to the patient during use.There were no reports of adverse effects to the patient as a result of the reported event.
Additional Manufacturer Narrative
The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation.The reported issue could not be verified and the cause of the reported issue could not be determined.
Event or Problem Description
A customer contacted physio-control to report that their electrodes did not work when connected to the patient during use.There were no reports of adverse effects to the patient as a result of the reported event.

• Brand Name: QUICK COMBO
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11788550
• Report Number: 0003015876-2021-01007
• Device Sequence Number: 19797018
• Product Code: DRX
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/25/2021

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: 11996
• Device Catalogue Number: 11996-000090
• Device Lot Number: 29350
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1