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

Model Number MODEL 100

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2015

Event Type  malfunction  

Event Description

It was reported that only the bottom half of the autopulse platform's lcd display is visible.The customer is unsure if this incident occurred during patient use or during a shift check.However, no adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on (b)(6) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation on 05/19/2015 investigation results are as follows: visual inspection was performed, which found that the battery lock and front enclosure were damaged.From the condition of the platform, the damage appears to have been caused by normal wear and tear.Functional testing was performed and the reported complaint was confirmed; the platform's lcd was defective.The lcd was replaced to remedy this issue and following its replacement, the platform passed functional testing with no further issues observed.Load cell characterization was also performed and both load cells were functioning within specification.A review of the platform's archive was performed which found that a user advisory (ua) 18 (max take-up revolutions exceeded) message occurred on the reported event date of (b)(6) 2015.Per autopulse® maintenance guide (p/n 11653-001), ua18 is exhibited when the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.At the time that this ua was exhibited, there was no recorded load change.Based on the investigation, the part identified for replacement was the lcd display, battery lock and front enclosure.In summary, the customer's reported complaint that the lcd display was defective was confirmed.Unrelated to the reported complaint, the platform displayed a user advisory (ua) 18 on the reported event date.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported ua 18.The platform passed load cell characterization testing, which confirmed that both load cells were functioning within specification.The platform passed all final functional testing criteria.

• 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: 4845242
• MDR Text Key: 20125014
• Report Number: 3010617000-2015-00329
• Device Sequence Number: 1
• Product Code: DRM
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/18/2015

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: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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