MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

During servicing on (b)(6) 2022, the autopulse platform (sn (b)(4) displayed user advisory (ua)27 (encoder fault).The root cause for the observed fault was due to the defective integrated encoder gearbox, likely attributed to a defective component.Upon visual inspection, zoll personnel observed damage to the top cover, front / bottom enclosure and a damaged battery compartment on ap platform.The probable root cause for the observed physical damage was due to mishandling.The top cover, front and bottom enclosures, and battery compartment were replaced to address the observed physical damages.The initial functional testing of the ap platform could not be performed due to (ua)27 (encoder fault) displayed upon powering on.The integrated encoder gearbox was replaced to remedy the issue.The worn out shaft lock plunger was also replaced.After service and replacement of parts, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The ap platform passed all functional tests.Historical complaints were reviewed for service information related to the reported issue and there was no similar complaint reported for autopulse platform with sn (b)(4).

Event Description

During the zoll investigation on (b)(6) 2022, the autopulse platform(sn (b)(4)) displayed user advisory - "(ua)27" (encoder fault) error message during initial functional testing.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13546380
• MDR Text Key: 287031446
• Report Number: 3010617000-2022-00140
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2022

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: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2007
• 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