MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECEIVER MODULE

Model Number 90478

Device Problems No Audible Alarm (1019); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Asystole (4442); Unspecified Heart Problem (4454)

Event Date 03/15/2022

Event Type  Death  

Manufacturer Narrative

The biomedical engineer evaluated the device after the event and verified proper functionality.A spacelabs field service engineer (fse) was dispatched to further evaluate the reported problem.The fse tested all spacelabs healthcare products referenced in the reported event, all tests passed and the equipment functioned as expected.A spacelabs healthcare customer care manager contacted the customer to gather additional information about the reported event and learned that the patient was connected to room rma01 in the drmau1 unit and the suspected missed alarms occurred between 12:00pm and 4:00pm on (b)(6) 2022.A copy of the identified patient's ics database record was reviewed and there is no evidence of any bradycardia, asystole, or atrial flutter events in the patient data.The spacelabs healthcare customer care manager has contacted the customer to share investigation findings and verify the identifying patient information.Should additional information be obtained, a supplemental report will be submitted in accordance with 21cfr 803.56.

Event Description

Spacelabs was notified that a telemetry receiver module did not generate alarms for bradycardia, asystole or atrial flutter events.The customer, a biomedical engineer reported this event caused a delay in patient care and may have contributed to the patient death.

Manufacturer Narrative

After the spacelabs healthcare customer care manager shared investigation findings with the customer and it was confirmed that incorrect patient information was reported to spacelabs for this event.The customer confirmed that the patient involved in the reported event was connected to room rmt02 in the dramau unit and the suspected missed alarms occurred between 12:00pm and 4:00pm on (b)(6) 2022.The customer care manager also confirmed that the spacelabs field service engineer evaluated the correct equipment while onsite investigating the reported issue.Our review of the patient's ics database record showed that the telemetry receiver module recognized the reported episode of bradycardia that transitioned to asystole and then generated a series of medium and high priority alarms for asystole, low hr, and high hr beginning at 12:40:21pm on (b)(6) 2022.Clinical parameters operations manual 070-2113-03 rev b states that the telemetry receiver module does not detect or alarm for the atrial flutter condition.Spacelabs will continue to follow up with the customer to share investigation findings.Should additional information be obtained, a supplemental report will be submitted in accordance with 21 cfr 803.56.H3 other text : placeholder.

Manufacturer Narrative

A spacelabs customer care manager contacted the customer and shared that our review of the patient's ics database record showed that the monitor appropriately generated several alarms for the reported event.The customer care manager also requested additional details of the reported event and clarification on how the alarms shown in the patient's database record could have been missed.The customer was unwilling to provide any additional details.This report is complete, and the issue is considered closed.

• Brand Name: SPACELABS TELEMETRY RECEIVER MODULE
• Type of Device: TELEMETRY RECEIVER 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 ; 425363-551
• MDR Report Key: 14257412
• MDR Text Key: 290441505
• Report Number: 3010157426-2022-00008
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K983996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,07/29/2022

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: 90478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• 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: 04/01/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 05/04/2022; 05/04/2022
• Supplement Dates FDA Received: 06/03/2022; 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2014
• 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 Outcome(s): Death