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

Model Number 91496

Device Problem Radio Signal Problem (1511)

Patient Problem Death (1802)

Event Date 03/15/2015

Event Type  Death  

Event Description

Spacelabs received a report that during cardiopulmonary resuscitation (cpr) on (b)(6) 2015 at approximately 5:01 p.M., a patient monitored with xprezzon bedside monitor model 91393 and command module model 91496 had a monitor display of poor quality ecg signal such that the clinical staff could not assess the waveform.This required exchange of the monitor during cpr.The patient did not survive cpr.

Manufacturer Narrative

A spacelabs field service engineer (fse) was dispatched to investigate the involved devices.The customer declined the fse access to devices since they were in use on another patient without issue.Spacelabs has launched an investigation into this event and will file a supplemental report upon completion of the investigation.Placeholder.

Manufacturer Narrative

The customer provided patient retrospective database was reviewed by a spacelabs software lead engineer.The following information was located in the database concurrent with the reported event: the ics database contains two ecg waveforms as well as spo2 and respiration waveforms from 2:07 p.M.On (b)(6) 2015 to 7:26 p.M.On (b)(6) 2015.At 5:03 p.M.On (b)(6) 2015, transcutaneous pacing was initiated when there was a drop in heart rate to 33 beats per minute.At 5:04 p.M.The primary ecg lead was changed from v1 to ii.At 5:05 p.M.Pacemaker detection was enabled on the monitor.The monitor began to display pacemaker flags.However, the artifact generated by the transcutaneous pacemaker continued to overwhelm the patient¿s intrinsic ecg.The monitor accurately captured the ecg waveform from the patient, though the pacing pulses from a transcutaneous pacemaker were so large that they obscured the patient¿s ecg.There was no malfunction of the spacelabs monitor or command module.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: 4639407
• MDR Text Key: 16863184
• Report Number: 3010157426-2015-00038
• 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,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/19/2015

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 Model Number: 91496
• Other Device ID Number: 2.05.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Death
• Patient Age: 79 YR