ARIA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-21 for ARIA * manufactured by Spacelabs Healthcare.

Event Text Entries

[2713330] The holter recorder was connected to the patient to record heart rate for 48 hours. When the monitor was taken off of the patient and connected to the computer to download the information, nothing was transferred. Test had to be repeated causing a delay in treatment. There are six additional devices that had broken cases which caused them to stop recording. These all lost either part or all of the recorded data. (either the battery compartment was broken so the battery was not seated properly and the device didn't record, or the case was broken such that the back of the device was not secure and the device did not operate). ======================manufacturer response for holter recorder, aria (per site reporter). ======================manufacturer repaired.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2585247
• MDR Report Key: 2585247
• Date Received: 2012-05-21
• Date of Report: 2012-05-16
• Date of Event: 2012-04-10
• Report Date: 2012-05-16
• Date Reported to FDA: 2012-05-21
• Date Added to Maude: 2012-05-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ARIA
• Generic Name: HOLTER RECORDER
• Product Code: MWJ
• Date Received: 2012-05-21
• Model Number: ARIA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 10 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SPACELABS HEALTHCARE
• Manufacturer Address: 5150 220TH AVENUE SE ISSAQUAH WA 98029 US 98029

Device Sequence Number: 2

• Brand Name: ARIA
• Generic Name: HOLTER RECORDER
• Product Code: MWJ
• Date Received: 2012-05-21
• Model Number: ARIA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 10 YR
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SPACELABS HEALTHCARE
• Manufacturer Address: 5150 220TH AVENUE SE ISSAQUAH WA 98029 US 98029

Device Sequence Number: 3

• Brand Name: ARIA
• Generic Name: HOLTER RECORDER
• Product Code: MWJ
• Date Received: 2012-05-21
• Model Number: ARIA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 10 YR
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: SPACELABS HEALTHCARE
• Manufacturer Address: 5150 220TH AVENUE SE ISSAQUAH WA 98029 US 98029

Device Sequence Number: 4

• Brand Name: ARIA
• Generic Name: HOLTER RECORDER
• Product Code: MWJ
• Date Received: 2012-05-21
• Model Number: ARIA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 10 YR
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: SPACELABS HEALTHCARE
• Manufacturer Address: 5150 220TH AVENUE SE ISSAQUAH WA 98029 US 98029

Device Sequence Number: 5

• Brand Name: ARIA
• Generic Name: HOLTER RECORDER
• Product Code: MWJ
• Date Received: 2012-05-21
• Model Number: ARIA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 10 YR
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: SPACELABS HEALTHCARE
• Manufacturer Address: 5150 220TH AVENUE SE ISSAQUAH WA 98029 US 98029

Device Sequence Number: 6

• Brand Name: ARIA
• Generic Name: HOLTER RECORDER
• Product Code: MWJ
• Date Received: 2012-05-21
• Model Number: ARIA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 10 YR
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: SPACELABS HEALTHCARE
• Manufacturer Address: 5150 220TH AVENUE SE ISSAQUAH WA 98029 US 98029

Device Sequence Number: 7

• Brand Name: ARIA
• Generic Name: HOLTER RECORDER
• Product Code: MWJ
• Date Received: 2012-05-21
• Model Number: ARIA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 10 YR
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: SPACELABS HEALTHCARE
• Manufacturer Address: 5150 220TH AVENUE SE ISSAQUAH WA 98029 US 98029

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-05-21