MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 1.0 DIA,W/SWITCH, 100-120V ONLY, PACKA; INTERNAL HANDLE

Model Number	1011-0139-01
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the associated device failed to discharge using these attached internal handles.Complainant indicated that the clinician obtained another device to continue treating the patient and reverted to pharmacology to convert the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The internal handles were returned to zoll medical corporation.Testing of the internal handles confirmed the reported malfunction.The customer was unable to provide the sterilization record but indicated that they may have put the handles through hundreds of sterilizations, well above the limit allowed in the operator?s guide.Investigation deemed that the handles met its useful life after they were sterilized past sterilization cycles limit.The handles were scrapped.Per the internal paddles operator's guide: when using hand washing, the internal handles are capable of withstanding 100 steam sterilization cycles.When using machine washing, the internal handles are capable of withstanding 50 steam sterilization cycles.The operator's guide also cautions that severe conditions of sterilization will limit the handles useful life.The product has been validated to these limits and sterilizing the product over its useful life can cause a breakdown in materials.Over time, failures such failing seals and fluid ingress may occur, compromising the effectiveness of the product.Its important to mention that the internal handles should be pretested prior to use as stated in the operators guide.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MAIH, 1.0 DIA,W/SWITCH, 100-120V ONLY, PACKA
• Common Device Name: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10356232
• Report Number: 1220908-2020-02455
• Device Sequence Number: 2301934
• Product Code: LDD
• UDI-Device Identifier: 00847946022327
• UDI-Public: 00847946022327
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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
• Operator of Device: Other
• Device Model Number: 1011-0139-01
• Device Catalogue Number: 1011-0139-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1