MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC. ELI 280; ELECTROCARDIOGRAPH

Catalog Number ELI280-CAA-AAFAD

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/10/2017

Event Type  malfunction  

Event Description

The bracket that holds the wireless acquisition module(wam) has broken.We continue to see this quite a bit; it should be reinforced.Manufacturer response for ekg cart, eli280 (per site reporter).We just order a new part and repair it.But even while under warranty this bracket was not covered.

• Brand Name: ELI 280
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT, INC.; 7865 north 86th st.; milwaukee WI 53224
• MDR Report Key: 6777174
• MDR Text Key: 82174020
• Report Number: 6777174
• Device Sequence Number: 1
• Product Code: DPS
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ELI280-CAA-AAFAD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2017
• 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
• Treatment: NO; NO OTHER THERAPIES