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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2016

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 during device check the autopulse platform (s/n (b)(4)) stopped compressions after a few compressions displaying a "low battery level" error.This was while using a known fully charge nimh battery (s/n (b)(4)).The customer tried two additional known fully charged nimh batteries (s/n's (b)(4)) with the same result.There was no patient involved with this event.Refer to mdrs 3010617000-2016-00144, 3010617000-2016-00145 and 3010617000-2016-00171.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) and 3 nickel metal hydride (nimh) batteries (s/n (b)(4)) were returned to zoll (b)(4) for evaluation.Investigation results as follows: a visual inspection of the returned autopulse platform was performed and found a crack near the screw hole.The autopulse is a reusable device and was manufactured on tbd.The physical damage found during visual inspection can occur due to normal wear and tear and/or physical abuse and is not related to the reported complaint of the platform stopped compression with error message of low battery level.A review of the archive showed user advisories (ua) 02 (compression tracking error), ua13 (battery fault detected), ua 44 (battery voltage too low during compression) and ua 45 (shaft not at "home" position) messages.The platform was functional tested and there were no problems or error messages noted using a fully charged battery.The reported event was not replicated.Testing of the 3 batteries shows that the power on the 3 nimh batteries was below 1300 w indicating the battery's capacity is below its nominal run time and the battery should be exchanged with a fully charged battery.Based on the investigation, there were no parts replaced.In summary the customer's reported complaint that the autopulse platform stopped after few compression with error message of low battery level was confirmed during archive review but not during functional testing.Although the customer stated that fully charged batteries were used, the power on the returned batteries was below 1300w which is below its nominal runt time.Therefore, the root cause for the platform stopping was the customer was using batteries that had below nominal run time capacity.

• 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: 5487061
• MDR Text Key: 39933290
• Report Number: 3010617000-2016-00143
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2008
• 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