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

Catalog Number 11996-000017

Device Problem Failure to Sense (1559)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.Physio-control 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.

Event Description

The customer contacted physio-control to report that they could not obtain an ecg on their lifepak 20e device.This issue is patient related; however there was no adverse event reported.

Event Description

The customer contacted physio-control to report that they could not obtain an ecg on their lifepak 20e device.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

The customer disposed of the electrodes involved in this event and therefore, they were not available for evaluation.The customer's device was returned for evaluation.The reported issue was unable to be duplicated.The customer's ecg leads were returned with the device and were noted to be 9 years past their expiry date.Additionally, the device's therapy cable was past its expiry date.The ecg leads and therapy cable were replaced to resolve the issue, and unrelated repairs were made to the device.After the device was observed to pass functional and performance testing, the device was returned to the customer.The root cause of the reported issue was most likely due to the aged cables being used.

• Brand Name: QUIK-COMBO
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10172336
• MDR Text Key: 195717809
• Report Number: 0003015876-2020-00776
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (y/n): N
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11996-000017
• Device Lot Number: 923821
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIFEPAK® 20E DEFIBRILLATOR/ MONITOR, MKJ, SN (B)(4).; LIFEPAK® 20E DEFIBRILLATOR/ MONITOR, MKJ, SN (B)(4).