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

Model Number MODEL 100

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse platform is cracked and the lifeband is damaged.The customer also reported that the platform is able to power on, however it will not work.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 05/26/2015 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 to zoll on 05/26/2015.Investigation results as follows: visual inspection of the returned platform was performed and found that the top cover is cracked thus confirming the reported complaint.The front enclosure, bottom enclosure and battery lock were also damaged.The physical damage found during visual inspection is unrelated to the customer's reported complaint of the platform would not work.A review of the archive showed numerous user advisory 07 (discrepancy between load1 and load2 too large) faults on the occurrence date of (b)(6) 2015.Ua 7 message is displayed when the load sensing system has detected a weight/load imbalance between the two load cells.Note that the device does not need to be performing compressions for this to occur; it may happen at any time when the device is powered on.The platform was run for 15 minutes with test manikin and 15 minutes with lrtf with no problems during compressions.Additionally, the platform also passed load cell characterization testing.Both load cell modules are within specification.Based on the investigation the top cover, front enclosure, bottom enclosure and battery lock were replaced.The physical damages found during visual inspection can occur due to normal wear and tear and/or physical abuse.In summary the customer's reported complaint that the platform will not work was confirmed during archive review.The root cause for ua 7 observed during archive review cannot be determined as both of the load cell modules were within specification.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.After replacement of the parts identified during visual inspection, 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: 4822273
• MDR Text Key: 5898279
• Report Number: 3010617000-2015-00318
• 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: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2007
• 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