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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

It was reported that the autopulse s/n (b)(4) would not start compressions and displayed user advisory 2 (compression tracking error) error.The customer used a known good battery and checked the lifeband was installed properly, which was.They were unable to clear the user advisory.No mention of patient involvement.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2015 for investigation.A visual inspection was performed and the load plate cover was found damaged.It was observed that the load plate cover have holes that would affect the sealing.Furthermore, fluid was observed to have ingress into the platform and corroded the metal layer of the top cover.In addition, both front and bottom covers were observed cracked at the screw holes area.The physical damage found is characteristic of use handling.A review of the archive was performed and a user advisor (ua) 7 (discrepancy between load 1 and load 2 too large) was observed.The platform was functional tested and the autopulse exhibited user advisor (ua) 7 (discrepancy between load 1 and load 2 too large) upon power up.The reported ua 2 could not be duplicated and was not observed in the archive date or upon powering up the platform.It was found that the load cell #2 was not functioning properly.In addition, the load cell characterization testing also confirmed that the load cell module was not working properly.Based on the investigation, the parts identified for replacement were the top, front and bottom covers, and the load cell module 2.In summary, the reported complaint of the platform displaying user advisory 2 upon power up was not confirmed based on the archive review and was not confirmed during functional testing.Unrelated to the reported complaint, the physical damage to the platform was attributed to user handling.The ua07 error message observed during functional test is unrelated to the reported complaint.The load cell module 2 was replaced to remedy the ua07.Following service, including replacement of the top, front and bottom covers, and the load cell module 2, the platform passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION 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: 5259112
• MDR Text Key: 32460354
• Report Number: 3010617000-2015-00639
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

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: 11/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2008
• 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