MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 2.0 DIA, 7 FT, W/SWITCH, 100-240V, PAC; INTERNAL HANDLE

Model Number 1011-0141-05-08

Device Problem Failure of Device to Self-Test (2937)

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

Event Type  malfunction  

Event Description

Complainant alleged that during biomed testing, the associated device failed self test using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The internal handles were returned to zoll medical germany for evaluation.The customer's report was observed an attributed to the returned internal handles.The internal handle set was scrapped at zoll germany to resolve the report.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MAIH, 2.0 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: 13208313
• MDR Text Key: 285733403
• Report Number: 1220908-2021-04661
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022976
• UDI-Public: 00847946022976
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/20/2021

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: 1011-0141-05-08
• Device Catalogue Number: 1011-0141-05-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 02/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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