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

Model Number 90478

Device Problem No Audible Alarm (1019)

Patient Problem Death (1802)

Event Date 05/21/2015

Event Type  Death  

Event Description

Spacelabs received a report that on (b)(6), 2015 at 10:16 a.M., no alarm was heard at the telemetry central monitor model 91387-38 for a sentinel event.The patient did not survive the event.The patient was monitored by telemetry transmitter model 91347 and telemetry receiver module model 90478.

Manufacturer Narrative

Onsite testing of the involved devices by a spacelabs field service engineer (fse) confirmed the equipment performed to specifications.The testing was witnessed by a facility staff member.As stated in the complaint, the facility biomed had previously performed alarm testing for ventricular bigeminy which is not an alarm arrhythmia for spacelabs telemetry products.It was also noted by the facility biomed and reviewed by the fse that the clinical staff had selected the lowest alarm tone volume for the central monitor.The patient retrospective database was provided by the customer for review by a spacelabs lead software engineer.The database confirmed the presence of an alarm that started at 10:14:07 a.M.And lasted for 588 seconds which includes the reported event time.The alarm began as a low rate alarm and transitioned to an asystole alarm.There was no product malfunction.This report is considered final and the issue closed.Placeholder.

• 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: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 4845849
• MDR Text Key: 5809956
• Report Number: 3010157426-2015-00126
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2015

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: 12/11/2014
• Device Model Number: 90478
• Other Device ID Number: 3.05.07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2008
• 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: (B)(4)
• Patient Outcome(s): Death