MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION SOLID GEL MFE, ADULT STERILE; ELECTRODE, DEFIB/PACE

Model Number 8900-4012

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/17/2015

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to treat a male patient (age unknown) in cardiac arrest, the associated device displayed a "poor pad contact" message.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.

• Brand Name: SOLID GEL MFE, ADULT STERILE
• Type of Device: ELECTRODE, DEFIB/PACE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 4516961
• MDR Text Key: 18784997
• Report Number: 1220908-2015-00275
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2015
• Device Model Number: 8900-4012
• Device Catalogue Number: 8900-4012
• Device Lot Number: 5014
• Other Device ID Number: 0084794601643
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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