MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONE STEP COMPLETE ELECTRODE, 8 PER CASE

Model Number 8900-0214

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Complainant alleged that during a routine shift check by a clinician, the device displayed a "poor pad contact" message.Complainant indicated that there was no pt involvement in the reported malfunction.

Manufacturer Narrative

Zoll med corp has not received the product for eval and this complaint is still under investigation.

• Brand Name: ONE STEP COMPLETE ELECTRODE, 8 PER CASE
• Type of Device: ELECTRODE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 4486503
• MDR Text Key: 5562090
• Report Number: 1220908-2015-00141
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-0214
• Device Catalogue Number: 8900-0214
• Other Device ID Number: 10847946016279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1