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

Model Number 91496

Device Problems Display Difficult to Read (1181); Radio Signal Problem (1511)

Patient Problem Death (1802)

Event Date 03/15/2015

Event Type  Death  

Event Description

Spacelabs received a report that after a transcutaneous pacer was placed and during cardiopulmonary resuscitation (cpr) on (b)(6), 2015 at approximately 12:07 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.The clinical staff changed electrodes, lead placement and monitor settings but this did not resolve the issue.The patient did not survive cpr.

Event Description

Spacelabs received a report that after a transcutaneous pacer was placed and during cardiopulmonary resuscitation (cpr) on (b)(6) 2015 at approximately 12:07 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.The clinical staff reportedly changed electrodes, lead placement and monitor settings but this did not resolve the issue.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

A spacelabs field service engineer (fse) was dispatched to investigate the involved devices.The customer declined device access to the fse since the involved devices were in use on another patient without issue.The customer did provide the patient retrospective database for the event.The database was reviewed by a spacelabs lead software engineer.The following information was obtained: the ics database contains 2 leads of ecg, respiration, oxygen saturation, arterial line pressure, pulmonary artery line pressure, and central venous line pressure waveforms from (b)(6) 2015 at 2:07 p.M.To (b)(6) 2015 at 12:33 p.M.(the event occurred (b)(6) 2015 at 12:07 p.M.).The patient was not connected to the monitor between 9:08 a.M.And 11:25 a.M.On (b)(6) 2015.At 11:54:55 a.M.A temporary transcutaneous pacemaker was activated for 98 seconds at a rate of 80 bpm.Between the end of the first session of external pacing at 11:56:33 a.M.And the beginning of the next external pacing at 12:07:11 p.M., the patient was in third degree heart block with evidence of an intra-aortic balloon pump augmenting the arterial blood pressure beginning at 11:59:37 a.M.At 12:07 p.M., transcutaneous pacing resumed, but at a much higher gain than the first session.The higher gain effectively obscures the ecg, though the effectiveness or ineffectiveness of the pacing is very accurately revealed by the simultaneous arterial line pressure.This pacing session continued until 12:21:47 p.M.Despite the report in the complaint, the database reveals that the monitored leads were never changed during the 15 minutes of transcutaneous pacing.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.Despite the lack of meaningful information from the ecg waveform, the invasive pressure waveform provided excellent feedback on the effectiveness of the temporary pacing.There is no evidence in the database that the monitored ecg leads were changed or the electrodes repositioned to mitigate the pacing artifact.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: 4639380
• MDR Text Key: 5617979
• Report Number: 3010157426-2015-00039
• 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,Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• 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
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 63 YR