MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES); INTERNAL PADDLE

Model Number 8011-0501-01

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during biomed testing, the associated defibrillator's defib output was out of specification using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.The malfunctions were attributed to the internal handle set.The internal handles were replaced to resolve the malfunction.The shock button was confirmed to be damaged.The handles were scrapped.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that during biomed testing, the associated defibrillator's defib output was out of specification using these internal handles.The complainant indicated that the switch was faulting.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES (MSERIES)
• Type of Device: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 7918272
• MDR Text Key: 122017340
• Report Number: 1220908-2018-02738
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K963781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8011-0501-01
• Device Catalogue Number: 8011050101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 09/09/2018
• Supplement Dates FDA Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1