MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION CPR STAT PADZ; ELECTRODES

Model Number 8900-0402

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 01/08/2015

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to treat a (b)(6) male patient, the electrodes would not adhere to the patient's skin.Complainant indicated that the clinician pressed down onto the electrode pads to the patient to continue treatment.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

• Brand Name: CPR STAT PADZ
• Type of Device: ELECTRODES
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824-4105 ; 9784219552
• MDR Report Key: 4512588
• MDR Text Key: 5532717
• Report Number: 1220908-2015-00243
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• Other Device ID Number: 00847946016319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• 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
• Patient Age: 66 YR