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

Catalog Number 11996-000017

Device Problems Unable to Obtain Readings (1516); Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the lot number of the chest pad is 015281 and the lot number of the side pad is 001984.Section, lot #, was intentionally left blank, as a single lot number associated with this product has not yet been identified.Physio-control contacted the customer to request additional information on the patient and concomitant lifepak device.No response has been received from the customer.Patient and product 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.

Manufacturer Narrative

Physio-control received additional patient information from the customer.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.

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

Physio-control received additional concomitant products from the customer.The customer provided physio-control with the available concomitant products.Device fields in which information is not provided were intentionally left blank.

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

Physio-control evaluated the customers device and was unable to duplicate the reported issue.The cause of the reported issue could not be determined.

• Brand Name: QUIK COMBO
• Type of Device: 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: 11064910
• MDR Text Key: 224411668
• Report Number: 0003015876-2020-01937
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11996-000017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DEFIBRILLATOR/MONITOR, PROCODE MKJ; LIFEPAK® 20E DEFIBRILLATOR/MONITOR,MKJ,(B)(6)
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: Asian