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

Model Number 91496

Device Problems Device Alarm System (1012); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2022

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has initiated an investigation into this matter.A supplemental report will be filed once the investigation is complete.

Event Description

The customer, a nurse, reported that during a patient procedure, their command module did not generate an alarm for an episode of tachycardia.It was also alleged that the command module did not provide an accurate spo2 reading.There was no harm to the patient or user was reported.

Manufacturer Narrative

Our review of the patent's ics database record confirmed the report of inaccurate heart rate readings during the event, which triggered several false alarms.It was also confirmed that there was no bradycardia or tachycardia present during the event at 3:17am a spacelabs field service engineer (fse) was dispatched to further evaluate the reported problem.The fse discussed the event with the hospital staff who clarified that their complaint is that the spacelabs monitoring equipment displayed inaccurrate heart rate readings on february 6, 2022.At 3:17am on february 6, 2022, the nurse saw an episode of bradycardia with a heart rate of 27 beats per minute (bpm).The nursing staff intervened and discovered that the patient's hr was actually above 100 bpm.The hospital staff clarified that there is no allegation of a failure to alarm associated with this event and there was no patient injury associated with the reported event.The fse tested the monitoring equipment used during the reported event and observed that inaccurate heart rate readings were being generated during testing.The fse and biomedical engineer also observed that the ecg lead wires in use contained visible wear on the leads and cracks in the insulation, the damaged lead wires were replaced and the reported issue involving inaccurrate heart rate readings was no longer present.The damaged lead wires were discarded after being replaced.The clinical parameters operations manual (b)(4) advises that all patient cables or sensors should be visually inspected at the time of use and warns that cables or sensors that exhibit obvious damage should not be used.The report is complete, and the issue is considered 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: matthew esparza ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635512
• MDR Report Key: 13743442
• MDR Text Key: 290310281
• Report Number: 3010157426-2022-00007
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/10/2022

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: Health Professional
• Device Model Number: 91496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/12/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• 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
• Patient Age: 34 WK
• Patient Sex: Female
• Patient Weight: 1 KG