MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECIEVER HOUSING; TELEMETRY HOUSING

Model Number 90479

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

Spacelabs field service engineer (fse) has investigated the situation.Upon investigation, findings show that one of the three receivers had been non-functional for a period of time and was not being used during this event.One of the remaining two receiver¿s function was restored by replacing the unit¿s battery.Per spacelabs service manual, maintenance is recommended annually, ¿the battery should be replaced at least every 12 months regardless of operation¿.Evidence showed that this maintenance had not been done.The second receiver was sent to sl for repair.It was replaced by a loaner unit while the repair is in progress.Spacelabs fse has assessed the current equipment and confirms that it is functioning as expected.Upon investigation of the returned unit, findings show that the issue was caused by a battery failure and an intermittent power switch.Replacing the faulty parts resolved the problem found with the device.The repaired device will be sent back to the customer.This report is complete and this particular issue is considered closed.

Event Description

Spacelabs received a report on (b)(6) 2019 that three telemetry receivers had suddenly went down.It was not known how many patients were involved.No injury was reported in relation to this event.

• Brand Name: SPACELABS TELEMETRY RECIEVER HOUSING
• Type of Device: TELEMETRY HOUSING
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: beth benner rn ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 8510166
• MDR Text Key: 142496056
• Report Number: 3010157426-2019-00016
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K925510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90479
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2012
• 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