MAUDE Adverse Event Report: CAIRE INC. SAROS; GENERATOR, OXYGEN, PORTABLE

Model Number 9400-SEQ

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The units are not going to be returned for investigations because no incident actually occurred.They were doing internal testing and determined there was a safety concern for alarms.When saros-3 was developed, a 510(k) was submitted for the current standard in 2009.This approval meant that the device met all the requirement standards including the applicable 60601 standards.This device was intended for military use and designed toward military specification and all alarm standards were outlined transparently in the manual, including the no flow alarm.Any subsequent changes to the firmware were a result of firmware "bugs" but no significant changes that would require a recertification to current test standards and this device is still compliant for its intended use based on the original 510(k) approval.The change in the no flow alarm for the recent firmware update was a customer driven request and the change was not driven out of compliance needs as it was already confirmed to be compliant based on the original 510(k) approval.

Event Description

No incident occurred.They were doing internal testing and determined there was a safety concern for alarms.The following is from a voluntary report filed: event description from voluntary event report from department of health & human services alarm system functionality presents a pt safety concern.System mode changes cause alarms to be disabled for five minutes.The manual states that "any change in mode will be followed by a 5 minute stabilization period.Alarms are not to be expected during this time." a mode change can be initiated by the operator.There are also conditions where an alarm state can trigger a mode change.Example: the system is in pulse mode and no breath is detected for 60 seconds.The system will initiate a no breath alarm and change the mode from pulse mode to continuous mode.Due to this change in mode, the alarm system is disabled for five minutes.The operator is given no indication that the system alarms are disabled.In effect, one alarm is disabling the other alarms for 5 minutes with no indication to the operator of the alarm system disabled state.This may not meet the intent of iec (b)(4) medical electrical equipment - alarm systems.Items are currently in stock at the army depot and fielded to army medical units.Vendor has stated new systems will have updated firmware to correct this issue.Army is concerned about fielded systems not just new systems.

• Brand Name: SAROS
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: neal maloy ; 2200 airport industrial drive; suite 500; ball ground, GA 30107
• MDR Report Key: 7987022
• MDR Text Key: 126229568
• Report Number: 3004972304-2018-00046
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9400-SEQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1