MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT*PADZ II ADULT MULTI-FUNCTION ELECTRODES; DEFIB/PACING ELECTRODES

Model Number 8900-0801-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem Death (1802)

Event Date 11/23/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a (b)(6) male patient, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.

• Type of Device: DEFIB/PACING ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 6165718
• MDR Text Key: 62085055
• Report Number: 1218058-2016-00153
• Device Sequence Number: 1
• Product Code: MKJ
• 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,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-0801-01
• Device Catalogue Number: 8900-0801-01
• Other Device ID Number: 00847946016326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2016
• 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 Outcome(s): Death
• Patient Age: 71 YR