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

Model Number MODEL 100

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

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

As reported, during device check, the autopulse platform (sn (b)(4)) made clicking sound and the lcd display went blank when the user powered on the platform.All the led lights on the platform were lit during the issue.No patient involvement.

Manufacturer Narrative

The reported event of "the autopulse platform (sn (b)(4) made clicking sound and the lcd display went blank when the user powered on the platform" was confirmed during the functional testing.The root cause for the device failed during power-on self-test was due to the defective processor pca (printed circuit assembly) board.Upon visual inspection, observed cracks on the front cover, unrelated to the reported problem.The physical damage was appeared to be due to user mishandling.The autopulse platform failed initial functional testing due to defective processor board.The processor board was replaced to remedy the issue.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, user advisory (ua) 27 (encoder fault) was noted.The encoder indicated that the drive shaft was turning too fast at the speed higher than 3000 rpm during compression due to the defective encoder.The encoder gearbox was replaced to remedy the issue.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8487665
• MDR Text Key: 141205193
• Report Number: 3010617000-2019-00266
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1