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

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

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 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.

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
• Type of Device: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10356232
• MDR Text Key: 201373931
• Report Number: 1220908-2020-02455
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022327
• UDI-Public: 00847946022327
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1