MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HP VIRIDIA TELEMETRY SYSTEM

Model Number M2600A

Device Problem Loss of Data (2903)

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

Event Type  malfunction  

Event Description

The customer reported that they lost monitoring for an entire wing of telemetry pts.There was no pt harm reported.

Manufacturer Narrative

(b)(4).A follow up report will be submitted upon completion of the investigation.

• Brand Name: HP VIRIDIA TELEMETRY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman rd.; andover, MA 01810 ; 9786597429
• MDR Report Key: 3937421
• MDR Text Key: 4533577
• Report Number: 1218950-2014-02105
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2014

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: Other
• Device Model Number: M2600A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: No
• 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