CAT 1 Escalation Process

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Instructions for documenting and escalating Category 1 (CAT 1) complaints.

Article ID: 3417

Resources

If you are not sure a complaint is a CAT 1 Escalation, refer to the Problem and Cause Code Guide (ID: 3963) for more details.
For non-CAT 1 complaints, follow the PER process detailed in Product Experience Report Form (PER Form) (ID: 3137)

Escalate to Leadership

The leadership team will process the PER form for Cat 1 complaints. Reach out to Leadership via email at ResupplyPatientCareLeadership@ResMed.com. Include CAT1 & the case# in the subject line.

CAUTION: Do not include any PHI in your email.

Your Salesforce case must include the following information:

First/Last Name
Phone Number
Device Serial Number
Part Number
HME Name/Phone number/Contact

CAT 1

There are six Category 1 escalated problem codes:

Death

A patient death has been reported

Death of a patient on a flow generator
OSA patient user of ResMed device died after a stroke
Death of patient on a portable oxygen concentrator

Fire/Flame

Device involved in a fire-related incident or evidence of smoke, burn, or melted parts

Caught on fire
Fire damaged
Device was smoking

Injury

Any actual or perceived injury not included in skin irritation or skin breakdown

Patient burns themselves on the humidifier
Patient had a stroke because device keeps shutting down
Patient had an electric shock because of therapy
Patient desaturated on a flow generator/ventilator/portable oxygen concentrator

Skin Irritation or Skin Breakdown

Rash, inflammation, irritation, or other breakdown of the skin

Mask is causing alignment of teeth to be off
Skull deformation from use of mask
Excessive bleeding on face
Deep wound around ears and cheeks

Mislabel or Incorrect Label

Device or packaging is labeled incorrectly

Lot number was missing off packaging
AirSense 10 has AirCurve 10 fascia
Device website is not accurate
Product label was not affixed to device

Melted

Melted appearance with no signs of flame

Tube melted
Climateline melted
Device case deformed

Article Metadata

The following table provides management and control details about the current published version of this article.

Prepared By	Hannah Vincent
Reviewed By	Clint Rodenfels
Process Owner	Diane Clarke
Subject Matter Expert	Nader Omar
Visibility	Internal - ACE
Revision Workflow	Standard
Archive Date
DAC	DAC4

Revision History

The following table summarizes changes for each published version of this article.

Date	Changes
3 April 2024	Added article tag "complaint"
22 February 2024	Added article tags "CAT1" and "CAT 1". Revised DAC. (K00243)
9 February 2024	Revised for clarity and to meet current editorial standards (K00133)
28 September 2021	Initial publication. All new content.