MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE

Model Number 91496

Device Problem No Audible Alarm (1019)

Patient Problem Death (1802)

Event Date 03/09/2015

Event Type  Death  

Event Description

Spacelabs received a report that an xprezzon bedside monitor model 91393 with command module model 91496 failed to generate an audible alarm for asystole while in patient use on (b)(6) 2015 at 7:14 a.M.There was a visual alarm of flashing red lights.The patient did not survive.

Event Description

Spacelabs received a report that on (b)(6) 2015 at 7:15 a.M.There was no audible alarm indication for an alarm condition that occurred with a uvsl command module model 91496 and xprezzon bedside monitor model 91393.No one was injured as a result of this event.

Manufacturer Narrative

Onsite testing of the involved devices by a spacelabs field service engineer (fse) confirmed that all equipment performed to specifications.Testing was witnessed by a facility staff member.Spacelabs has launched an investigation into this event and will file a supplemental report upon completion of the investigation.Placeholder.

Manufacturer Narrative

Onsite testing of the involved devices by a spacelabs field service engineer (fse) confirmed the products performed to specifications.The testing was witnessed by a facility staff member.The customer provided the patient retrospective database which was reviewed by a spacelabs lead software engineer.The following information was obtained: leads ii and v1 were the monitored leads at the time of the complaint episode.On (b)(6) at 6:24 a.M., monitoring initiated.At this time, ecg rate alarm limits were 150 bpm (high rate limit) and 125 bpm (low rate limit).On (b)(6) from 6:24 a.M., a high priority alarm for ecg high rate was initiated.Alarm continued until (b)(6) at 6:48 a.M.On (b)(6) at 6:24 a.M., a high priority alarm for resp high rate was initiated.Alarm continued until (b)(6) at 7:04 a.M.On (b)(6) at 7:07 a.M., a high priority alarm was initiated.Alarm continued until (b)(6) at 7:10 a.M.When the ecg low rate limit was manually adjusted to 86 bpm (or less).On (b)(6) at 7:15 a.M., a high priority alarm for resp low rate was initiated.On (b)(6) at 7:16 a.M., there is an ecg (stacked) alarm record in the ics database indicating that multiple high-priority alarms were simultaneously active.Thereafter, numerous high priority ecg and resp alarms were active throughout the next 21 minutes.The presence of the alarm records in the database shows that the alarm conditions were appropriately identified by the monitoring system.At this time, we know of no reason that audible alarm indications would not have also been present at the time of the event as these indicators operated according to specifications when tested by a spacelabs fse.There was no product malfunction demonstrated per onsite product testing by a spacelabs fse or by review of the retrospective database by a spacelabs lead software engineer.This report is considered final and the issue closed.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: ULTRAVIEW SL MULTIPARAMETER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 4639420
• MDR Text Key: 5598028
• Report Number: 3010157426-2015-00040
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2015
• Device Model Number: 91496
• Other Device ID Number: 2.04.03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 91393 ((B)(4)); 91393 ((B)(4))
• Patient Outcome(s): Death