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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2014, medics responded to a (b)(6) year old male patient in cardio pulmonary arrest.After the autopulse platform was removed from the carry case and the patient was placed on the device, it was noticed that the housing at the head had completely separated from the platform.They attempted to use the platform but it did not power on.The crew reverted to manual cpr (exact length of time was not provided).No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Further examination by the customer showed that all of the platform's screws were loose and some were ready to fall out.Customer indicated that the platform ran later at the station when the head section was held together with a zip tie.The autopulse platform in complaint was returned to zoll on 12/10/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection was performed and the reported complaint of the platform covers being damaged was confirmed.The following was observed: the top cover, motor cover, encoder cover, patient restraint assembly, restraint pin assembly and battery cover were damaged.From the condition of the returned unit, the damages appear to have been due to wear and tear.The reported complaint of the platform not powering on to perform compressions could not be confirmed.The platform ran for 25 minutes with a test mannequin and an additional 30 minutes with a large resuscitation test fixture (lrtf), with no issues encountered.The platform passed functional testing.There were no user advisories observed on the reported event date of (b)(6) 2014.Based on the investigation, the part(s) identified for replacement were the top cover, motor cover, encoder cover, patient restraint assembly, restraint pin assembly and battery cover.In summary, the reported complaint of the platform covers being damaged was confirmed during visual inspection and attributed to wear and tear.The reported complaint of the platform not powering on to perform compressions could not be duplicated.The platform passed all functional testing.Following service, including replacement of the damaged parts, 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: 4362748
• MDR Text Key: 18920486
• Report Number: 3010617000-2014-00677
• 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
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

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: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2005
• 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
• Treatment: MANUAL CPR
• Patient Age: 54 YR