Nellcor bedside SpO2 monitor alarms may not be heard or recognized

Plain-English summary

The Covidien Nellcor Bedside SpO2 Patient Monitoring System is being recalled across REF numbers PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP and 10005941JPN. The action covers 264,790 units.

The stated reason is that Bedside SpO2 Patient Monitoring System alarms may not be heard or recognized, resulting in treatment delay, lack of low oxygen saturation response, respiratory failure and arrhythmia. The manufacturer is highlighting three points in the operator's manual: for patient safety, do not silence or decrease the alarm volume; the sensor off alarm, meaning no perfusion detected, is a low priority alarm; and monitors should be set to Homecare Mode outside a hospital or professional setting. The FDA classified the action as Class II.

Distribution was worldwide, including nationwide across a large number of US states.

Facilities and home users should identify affected monitors using the REF and UDI codes in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product

Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN

Manufacturer

Covidien

Category

Medical Device — Patient monitor

Hazard

• alarm-not-heard
• pulse-oximetry
• treatment-delay
• class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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