MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 1.6 DIA, 7 FT, W/SWITCH, 100-240V, PAC; INTERNAL HANDLE

Model Number 1011-0141-02-36

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 a routine shift check by a clinician, the associated device displayed a "check pads" message while using these internal paddles.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The internal handles were returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The internal handles were put through extensive testing including full functional stress testing without duplicating the report.The internal handles were scrapped.The device activity logs and multifunction cable were not returned for evaluation.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MAIH, 1.6 DIA, 7 FT, W/SWITCH, 100-240V, PAC
• Type of Device: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 15124241
• MDR Text Key: 296860006
• Report Number: 1220908-2022-02873
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1011-0141-02-36
• Device Catalogue Number: 1011-0141-02-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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