MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR

Model Number 8900-0800-01

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem Necrosis (1971)

Event Date 03/16/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a (b)(6)-year-old male patient, the pads were damaged during opening/removal of packaging and they were unable to attach them to the patient causing a delay in therapy.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Photographs of the customer's report were provided by the customer as part of the investigation.The photographic evidence showed that the electrode pads were assembled properly to the coated side of the styrene plastic liner.This determination was made by the folds and marking and the labels on the styrene shown in the photos.The photos suggest that at some point, the pads were removed from the coated side and were re-applied to the non-coated side of the styrene liner.This prevented any further removal from the styrene.A retained sample evaluation of lot 1020 was performed.The retained sample was unable to duplicate the customer's report.Our investigation for the customer's report was unsubstantiated.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11575276
• MDR Text Key: 242432997
• Report Number: 1218058-2021-00036
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946000189
• UDI-Public: 00847946000189
• Combination Product (y/n): N
• PMA/PMN Number: K011541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-0800-01
• Device Catalogue Number: 8900-0800-01
• Device Lot Number: 1020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR