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

Model Number 8011-0501-01

Device Problem Energy Output Problem (1431)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during biomed testing, the device's defib output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device was evaluated by zoll medical (b)(4).The reported problem was observed during testing.The discharge values were out of range.The autoclavable handle was sent to zoll medical (b)(4) for evaluation.Evaluation of autoclavable handle could not duplicate the reported malfunction.The handle was scrapped.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES
• 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: 8142399
• MDR Text Key: 129632037
• Report Number: 1220908-2018-03558
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• 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: 12/04/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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