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

Model Number MODEL 100

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll for investigation on 08/03/2015.Investigation results as follows: visual inspection of the returned platform was performed which found that the top cover wire strands were cut.The physical damage found during visual inspection is unrelated to the customer's reported complaint of the autopulse platform's lcd display flashing on/off.The reported complaint was confirmed during functional testing.Further inspection identified that the processor pca was defective.Functional testing was still able to be performed and no user advisories or warnings were observed.Load cell characterization testing was also performed which showed that both load cells were functioning within specification.A review of the platform's archive was performed and no user advisories or warnings were observed on the reported event date of (b)(6) 2015.Based on the investigation, the parts identified for replacement were the top cover and processor pca board.In summary, the customer's reported complaint of the autopulse platform's lcd display flashing on and off was confirmed and is attributed to the processor pca being defective.A review of the platform's archive data was also performed and did not indicate any problems related to the reported complaint.The physical damage found during visual inspection is unrelated to the reported complaint.These types of damages can occur due to normal wear and tear and/or physical abuse.After replacement of the identified parts during investigation, the returned platform passed all final functional testing criteria.

Event Description

It was reported that the lcd display of the autopulse platform was flashing on and off, upon power up.Other than that, the device functions properly.There was no report of any patient involvement.No further information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5022975
• MDR Text Key: 23857094
• Report Number: 3010617000-2015-00466
• 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: health professional
• Reporter Occupation: Health Professional
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• 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: 08/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2011
• 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