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

Model Number MODEL 100

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 06/18/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned on 7/7/2015 to zoll for evaluation.Investigation results are as follows: visual inspection was performed which found that the screws at the encoder and bottom cover were missing.The battery partition cover and patient restraint pin were also observed to be missing.From the condition of the platform, the damages appear to have been caused by normal wear and tear (autopulse manufactured 6/2005).The platform was functionally tested for 10 minutes using test mannequin and no problems were observed.The autopulse platform passed functional testing.The reported complaint of the battery pin being damaged, resulting in removal difficulties from the platform was observed, thus confirming the reported complaint.Further inspection identified that the battery connector on the power distribution board was damaged and needed to be replaced.A review of the platform's archive was performed and it was observed that user advisories (uas) ua18 (max take-up revolutions exceeded) and ua13 (battery fault detected) occurred on the reported event date of (b)(6) 2015.However, these codes are unrelated to the reported complaint.User advisory (ua) 13 was observed on the reported event date while the platform was in use with li-ion battery (s/n (b)(4)).This battery was manufactured in april 2013.No issues related to improper battery management were observed.This battery was fully charged at time of use with the autopulse platform.Based on the investigation, the parts identified for replacement were the power distribution board, the top cover, restraint pin assembly, and battery partition cover.In summary, the reported complaint was confirmed during functional testing and is attributed to the damaged battery connector on the power distribution board.The power distribution board was replaced to remedy the reported complaint.In addition, the top cover, restraint pin and battery partition cover were also replaced.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the user advisory 18 and 13 codes.However, 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.A root cause for ua13 code could not be determined.The physical damage found during visual inspection is unrelated to the reported complaint.The platform is a reusable device and therefore, these types of physical damages can occur due to normal wear and tear and/or physical abuse.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

Event Description

It was initially reported that on (b)(6) 2015, the battery pin inside the autopulse platform appeared to be damaged.Customer indicated that when an autopulse li-ion battery was inserted into the platform, it was difficult to remove.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that a user advisory (ua) 13 (battery fault detected) and 18 (max take-up revolutions exceeded) occurred on the reported event date.Although the customer did not report this, user advisories (uas) 13 and 18 are considered reportable malfunctions.

• 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: 4950451
• MDR Text Key: 23134065
• Report Number: 3010617000-2015-00436
• 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
• Reporter Occupation: Health Professional
• Report Date: 06/18/2015

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: 07/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2005
• 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