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

Model Number MODEL 100

Device Problem Device Inoperable (1663)

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

Event Date 02/26/2015

Event Type  malfunction  

Event Description

It was reported that during a call, the autopulse platform stopped operating multiple times and had to be restarted.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 03/16/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Please see the following related mfr.Report #3010617000-2015-00170 for autopulse® li-ion battery with sn: (b)(4).

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection was performed and no physical damages were observed to the device.The platform was functionally tested using a large resuscitation test fixture for several hours with no user advisories, system errors or warnings exhibited.The platform performed as intended during functional testing.A review of the platform's archive data shows that on the reported event date of (b)(6) 2015, the following messages were displayed on the platform: user advisory (ua) 2 (compression tracking error), warning 1 (low battery warning), ua 4 (battery charge state too low - replace battery), ua 17 (max motor on time exceeded during active operation) and ua 18 (max take-up revolutions exceeded).Further review of the platform's archive shows that, on (b)(6) 2015, the autopulse platform was used with li-ion battery with s/n (b)(4), which was charged with a high remaining capacity at the time of initial use.The platform stopped compressions multiple times resulting in multiple ua 17 codes, followed by a ua 2 code, a warning 1 and multiple ua 4 codes.Based on the archive showing multiple stoppages, the reported complaint is confirmed.It should be noted that li-ion battery (s/n (b)(4)) could not be located by the customer at the customer's site and was therefore unavailable for evaluation.Evaluation of the platform did not identify any issues which may have caused or contributed to the ua 17 codes.Specifically, a brake gap inspection was performed and verified that the brake gap was within the specification of 0.008" ±0.001", thus ruling this out as a potential cause.Based on full evaluation of the device and archive data, the ua 17 codes likely occurred as a result of the patient being misaligned on the platform or the lifeband becoming twisted.The warning 1 and ua 4 codes occurred as expected and were a result of the battery charge eventually depleting and subsequently having insufficient remaining charge capacity at the time these messages were displayed.Based on the archive, the cause of the ua 2 was likely due to the patient being misaligned on the platform or the lifeband being opened.The ua 18 codes observed in the archive occurred after the reported patient event and are unrelated to the reported complaint.At the time of the ua 18 codes, there was no patient on the platform.Therefore, the cause of the ua 18 codes was determined to be no load change detected at the load plate.Based on the investigation, no part(s) were identified for replacement.In summary, the reported complaint was confirmed during review of the platform's archive data.The archive showed that the platform stopped operating multiple times followed by multiple ua 17 codes, a ua 2 code, a warning 1 and multiple ua 4 codes.There were no mechanical issues with the platform that may have caused or contributed to these observed codes.The ua 17 codes likely occurred as a result of a misaligned patient on the platform or a twisted lifeband.The cause of the ua 2 is likely due to patient misalignment on the platform or the lifeband being opened.The warning 1 and ua 4 codes occurred as expected due to the battery charge eventually depleting and subsequently having insufficient remaining charge capacity.Multiple ua 18 codes were also seen on the reported event after the patient event and were a result of no load detected at the platform's load plate due to no patient on the platform at the time.The ua 18 codes are unrelated to the patient event.

• 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: 4633578
• MDR Text Key: 5574915
• Report Number: 3010617000-2015-00169
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• 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: 8700-0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2009
• 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