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

Model Number MODEL 100

Device Problems No Display/Image (1183); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform however, the investigation is pending.A follow-up report will be submitted when the investigation has been completed.

Event Description

During shift check, customer reported that the autopulse platform (serial (b)(4)) does power on but the display was blanked and makes constant clicking sounds.The customer replaced with new autopulse li-ion batteries on the platform but issue persisted.No patient involvement.

Manufacturer Narrative

The reported complaints of blank display screen and makes constant clicking sounds on the autopulse platform (serial #34987) was not confirmed during functional test and visual inspection.However, returned autopulse platform displayed a user advisory "(ua)132" (internal watchdog timeout (system error)) but no constant clicking sounds noise.The lcd display is functioning as intended.There was no physical damage was observed on the returned autopulse platform.The initial functional test failed due to returned autopulse platform displayed "(ua)132" (internal watchdog timeout (system error)) during power on.To remedy the "(ua)132", the processor board was replaced.This issue is considered related to the reported complaint, at some point the platform intermittently had a blank screen.After service completion, 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 autopulse platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history complaint reported for autopulse with serial number (b)(4).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9448377
• MDR Text Key: 178665395
• Report Number: 3010617000-2019-01095
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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?: Yes
• Date Returned to Manufacturer: 11/20/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1