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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported issue of the autopulse exhibited user advisory (ua) 42 (force overload tripped) error message was not confirmed during the archive review and the initial functional testing.However, unrelated to the reported complaint, user advisory (ua) 41 (patient temperature sensor failure) error was displayed during platform testing.Temperature sensor was replaced to remedy the fault.Visual inspection was performed and found no physical damage to the autopulse platform.Additionally, unrelated to the reported complaint, the encoder drive shaft was noticed to be not rotating smoothly, exhibits binding and resistance.Functional testing was performed; the autopulse platform passed functional tests without exhibiting any fault or user advisory (ua) 42 error.Review of the archive data show no (ua) 42 error messages occurred on the reported event date of (b)(6) 2018, however, unrelated to the reported complaint, archive shows multiple user advisory (ua) 41 (patient temperature sensor failure) errors occurred on the same day.Following service, clutch plate deburring was performed to remedy the sticky clutch noted during visual inspection.Additionally, as a precautionary measure, the power distribution board (pdb) was replaced.After repair, the autopulse passed all final testing with no faults found.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

During patient use, the autopulse platform (sn (b)(4)) displayed an error message user advisory (ua) 42 (force overload tripped).No further information was provided.No known impact or patient consequence was reported.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7494918
• MDR Text Key: 108316142
• Report Number: 3010617000-2018-00529
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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