MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XPREZZON BEDSIDE MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 94267-19

Device Problem Battery Problem (2885)

Patient Problem No Code Available (3191)

Event Date 06/22/2017

Event Type  malfunction  

Event Description

During the last power outage, there was a problem with a patient room retaining data.The battery had already been replaced.Due to a patient in the room, we could not verify if the new battery was defective, so another was ordered to be safe.Please see attached wo for the battery replacement.Email was sent to medsun for review.Six patients were affected.

• Brand Name: SPACELABS XPREZZON BEDSIDE MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• MDR Report Key: 6705538
• MDR Text Key: 79764418
• Report Number: 6705538
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 94267-19
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1