Model Number 22042 |
Device Problems
Premature Discharge of Battery (1057); Incorrect Measurement (1383)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/22/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional manufacturing narrative: the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
|
|
Event Description
|
The customer reported the device is not holding a charge for very long, and does not provide good readings.No patient impact, or consequences were reported.
|
|
Manufacturer Narrative
|
Additional manufacuring narrative: other, other text: the returned device was evaluated.External visual inspection showed no damage.The device was able to power on using both ac and battery power.When powered on the unit could obtain readings and alarmed audibly and visually under alarm conditions.The device passed both manual and preset measurement tests for spo2 and pulse rate.No issues related to measurement accuracy were identified.The battery would only power the device for three (3) hours prior to shutting down with a low battery alarm.The customer's complaint regarding readings was not confirmed however the device battery did not hold a charge for the required length of time.A service history record review reveals that this unit was in the field for over four (4) years with no previous reported issues related to this reported event.
|
|
Event Description
|
The customer reported the device is not holding a charge for very long and does not provide good readings.No patient impact or consequences were reported.
|
|
Search Alerts/Recalls
|